Organon and Co (OGN)

Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19June 10, 2026 7:30 AM
Business Wire Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE® (tocilizumab-bavi) injection, for intravenous use, a biosimilar to ACTEMRA (tocilizumab). The approval expands TOFIDENCE indications to include treatment of: (1) adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) and (2) hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). “The approval of these new indications for TOFIDENCE is a vital step forward in expanding access to treatment options that address critical needs, including for patients facing CRS, a serious side effect of CAR-T therapies,” said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon.1,2 “In the US, biosimilar adoption may help reduce the affordability burden of high-cost brand biologics on the health care system.3 By expanding the use of TOFIDENCE, we continue to advance our biosimilars portfolio and our commitment to broadening access to high-quality treatment options for patients in need.”1,3 TOFIDENCE, the first approved tocilizumab biosimilar entrant in the US market, was launched in May 2024 and is also indicated in appropriate patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.4,5 See full indications below. TOFIDENCE injection is available in the following presentations: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20mL (20 mg/mL), in single-dose vials for further dilution prior to intravenous infusion. Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TOFIDENCE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. See additional safety information below. Organon acquired the regulatory and commercial rights to TOFIDENCE in the US in 2025. Bio-Thera Solutions Ltd., the product developer, maintains manufacturing rights for TOFIDENCE for the US market.5 About TOFIDENCE® (tocilizumab-bavi) TOFIDENCE is an interleukin-6 (IL-6) receptor antagonist indicated for: Rheumatoid Arthritis (RA): TOFIDENCE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA): TOFIDENCE is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (PJIA): TOFIDENCE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older. Systemic Juvenile Idiopathic Arthritis (SJIA): TOFIDENCE is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older. Cytokine Release Syndrome (CRS): TOFIDENCE is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older. Coronavirus Disease 2019 (COVID-19): TOFIDENCE is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). SELECTED SAFETY INFORMATION RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before TOFIDENCE use and during therapy. Treatment for latent infection should be initiated prior to TOFIDENCE use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral, and other infections due to opportunistic pathogens. Do not administer TOFIDENCE in patients with an active infection, including localized infections. The risks and benefits of treatment with TOFIDENCE should be carefully considered prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TOFIDENCE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Hold TOFIDENCE if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with TOFIDENCE should undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor the patient. COVID-19 In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with TOFIDENCE. Tuberculosis Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating TOFIDENCE. Consider anti-tuberculosis therapy prior to initiation of TOFIDENCE in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Closely monitor patients for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before initiating TOFIDENCE. Viral Reactivation Viral reactivation has been reported with immunosuppressive biologic therapies and cases of herpes zoster exacerbation were observed in clinical studies with tocilizumab. CONTRAINDICATIONS TOFIDENCE is contraindicated in patients with known hypersensitivity to tocilizumab products. WARNINGS AND PRECAUTIONS GASTROINTESTINAL PERFORATIONS Use TOFIDENCE with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with fever, new onset abdominal symptoms, and change in bowel habits for early identification of gastrointestinal perforation. HEPATOTOXICITY Serious cases of hepatic injury have been observed in patients taking intravenous tocilizumab products. Some of these cases have resulted in liver transplant or death. For rheumatoid arthritis (RA) and giant cell arteritis (GCA) patients, obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) before initiating TOFIDENCE routinely. It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with elevated transaminases ALT or AST greater than 1.5 x upper limit of normal (ULN). In patients who develop elevated ALT or AST greater than 5 x ULN, discontinue TOFIDENCE. It is not recommended to initiate TOFIDENCE treatment in COVID-19 patients with elevated ALT or AST above 10 x ULN. Monitor ALT and AST during treatment. Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. If the patient is found to have abnormal liver tests, TOFIDENCE treatment should be interrupted and investigation done to establish the probable cause. TOFIDENCE should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests. A similar pattern of liver enzyme elevation is noted with tocilizumab products treatment in the polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) populations. Monitor liver test panel at the time of the second administration and thereafter every 4 to 8 weeks for PJIA and every 2 to 4 weeks for SJIA. CHANGES IN LABORATORY PARAMETERS Patients with RA, GCA, and COVID-19: Neutropenia Treatment with tocilizumab products was associated with a higher incidence of neutropenia. It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with a low neutrophil count, ie, absolute neutrophil count (ANC) less than 2000 per mm3. In patients who develop an ANC less than 500 per mm3, treatment is not recommended. It is not recommended to initiate TOFIDENCE treatment in COVID-19 patients with an ANC less than 1000 per mm3. Neutrophils should be monitored. Monitor neutrophils 4 to 8 weeks after start of therapy and every 3 months thereafter. Thrombocytopenia Treatment with tocilizumab products was associated with a reduction in platelet counts. It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with a platelet count below 100,000 per mm3. In patients who develop a platelet count less than 50,000 per mm3, treatment is not recommended. Monitor platelets 4 to 8 weeks after start of therapy and every 3 months thereafter. In COVID-19 patients with a platelet count less than 50,000 per mm3, treatment is not recommended. Elevated Liver Enzymes Refer to Hepatotoxicity. (See above.) Lipid Abnormalities Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol. Assess lipid parameters approximately 4 to 8 weeks following initiation of TOFIDENCE therapy. Patients with Polyarticular and Systemic Juvenile Idiopathic Arthritis: A similar pattern of liver enzyme elevation, low neutrophil count, low platelet count, and lipid elevations is noted with tocilizumab products treatment in the PJIA and SJIA populations. Monitor neutrophils, platelets, ALT, and AST at the time of the second administration and thereafter every 4 to 8 weeks for PJIA and every 2 to 4 weeks for SJIA. Monitor lipids as above for approved adult indications. IMMUNOSUPPRESSION TOFIDENCE is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies. HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab products and anaphylactic events with a fatal outcome have been reported with intravenous infusion of tocilizumab products. Reactions that required treatment discontinuation included generalized erythema, rash, and urticaria. TOFIDENCE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. If a hypersensitivity reaction occurs, immediately discontinue TOFIDENCE; treat promptly, and monitor until signs and symptoms resolve. DEMYELINATING DISORDERS Prescribers should exercise caution in considering the use of TOFIDENCE in patients with preexisting or recent onset demyelinating disorders. ACTIVE HEPATIC DISEASE AND HEPATIC IMPAIRMENT Treatment with TOFIDENCE is not recommended in patients with active hepatic disease or hepatic impairment. VACCINATIONS Avoid use of live vaccines concurrently with TOFIDENCE as clinical safety has not been established. No data are available on the effectiveness of vaccination in patients receiving tocilizumab products. Because interleukin-6 (IL-6) inhibition may interfere with the normal immune response to new antigens, it is recommended that all patients, particularly pediatric or elderly patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating TOFIDENCE therapy. ADVERSE REACTIONS The most common adverse reactions (incidence of at least 5%) associated with tocilizumab-IV were upper respiratory tract infection, nasopharyngitis, headache, hypertension, and increased ALT. DRUG INTERACTIONS Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates. Exercise caution when coadministering TOFIDENCE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, eg, oral contraceptives, lovastatin, atorvastatin, etc. USE IN SPECIFIC POPULATIONS Pregnancy The available data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on the animal data, there may be a potential risk to the fetus. Lactation No information is available on the presence of tocilizumab products in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Discontinue the drug or nursing, taking into consideration the importance of the drug to the mother. Before prescribing TOFIDENCE, please read the Prescribing Information, including the Boxed Warning about serious infections. The Medication Guide also is available. About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations regarding the anticipated impact and potential benefits to Organon of the expanded indications for TOFIDENCE. Forward-looking statements may be identified by words such as “will,” “may,” “continue,” “commitment to broadening,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. ACTEMRA is a trademark registered in the US by Chugai Seiyaku Kabushiki Kaisha; Organon is not associated with this trademark owner. References Overview for health care professionals. US Food and Drug Administration. Updated August 1, 2024. Accessed February 23, 2026. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals Cytokine release syndrome. Cleveland Clinic. Updated July 14, 2025. Accessed May 27, 2026. https://my.clevelandclinic.org/health/diseases/22700-cytokine-release-syndrome Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability. IQVIA Institute for Human Data Science. January 31, 2023. Accessed February 5, 2026. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027 FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis. US Food and Drug Administration; September 29, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis Organon acquires TOFIDENCE™ (tocilizumab-bavi), a commercialized biosimilar to ACTEMRA® (tocilizumab) injection, for intravenous infusion in the U.S. Press release. Organon; April 1, 2025. https://www.organon.com/news/organon-acquires-tofidence-tocilizumab-bavi-a-commercialized-biosimilar-to-actemra-tocilizumab-injection-for-intravenous-infusion-in-the-u-s/ © 2026 Organon group of companies. All rights reserved. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. View source version on businesswire.com: https://www.businesswire.com/news/home/20260610519993/en/ Media Contacts: Janine Colavita
(732) 861-3806 Karissa Peer
(614) 314-8094 Investor Contacts: Jennifer Halchak
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(551) 204-6129 Original: Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19

Organon to Present New Research on Access and Value at ISPOR 2026May 15, 2026 7:30 AM
Business Wire New findings will highlight contraception affordability, biosimilar adoption, and access-focused analyses across the women’s health and general medicines portfolio Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present data across women’s health, biosimilars, dermatology, and neurology at ISPOR 2026, the leading global scientific conference hosted by the International Society for Pharmacoeconomics and Outcomes Research. The conference, focused on health economics and outcomes research, will take place May 17-20, 2026, in Philadelphia, Pennsylvania. Across 8 accepted abstracts, the data reflect Organon’s commitment to generating real-world evidence—rooted in lived experiences—that can help inform healthcare decision-making and improve health outcomes across a range of therapeutic areas. “Health economics and outcomes research is critical to ensuring the right treatments reach patients and that health systems can sustain this approach over time,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. “At ISPOR 2026, Organon is proud to share research findings about the budget impact, referral patterns, and real-world evidence of treatments for contraception, dermatology, and neurology conditions—each grounded in evidence that puts patient and provider perspectives at the center.” Key data from Organon’s portfolio to be presented include: An examination of the cost-effectiveness and budget impact of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque in Brazil, including analyses that incorporate real-world utilization data and private payer perspectives. A budget impact analysis of VTAMA® (tapinarof) cream, 1%, for the treatment of atopic dermatitis in adult and pediatric patients (2 years of age and older) from a U.S. Medicaid plan perspective. Analyses related to POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use in certain HER2-positive breast cancer, as well as a real-world budget impact analysis of biosimilar adoption in a mid-sized Brazilian health maintenance organization. An exploration of real-world referral patterns and healthcare utilization among patients with headache disorders in the United Kingdom, contributing to a better understanding of patient pathways and healthcare resource use in neurology. Details on the abstracts noted above and additional presentations (including dates and times) can be found below. See below for full product information, including indication and selected safety information. Date and Time (all times listed in EDT) Abstract Name Monday, May 18, 2026 | Poster Session 1 | 10:30 AM-1:30 PM 12:30 PM-1:30 PM: EE71 – Management Based on the Institutionalization of Health Technology Assessment (HTA): The Case of the Etonogestrel Subdermal Implant in a Brazilian Private Health Insurance Plan 12:30 PM-1:30 PM: EE57 – Budget Impact and Cost Calculator Model for POHERDY® (pertuzumab-dpzb) in the Treatment of HER2-Positive Breast Cancer Monday, May 18, 2026 | Poster Session 2 | 4:00 PM-7:00 PM   6:00 PM-7:00 PM: EE174 – Cost-Effectiveness and Budget Impact of the Etonogestrel Subdermal Contraceptive Implant in Brazil 6:00 PM-7:00 PM: EE100 – Real-World Budget Impact Analysis of Biosimilar Adoption in a Mid-Sized Brazilian Health Maintenance Organization 6:00 PM-7:00 PM: EE172 – Cost-Effectiveness and Budget Impact of the Etonogestrel Subdermal Implant Incorporating Real-World Utilization Data from a Large Brazilian Private Health Insurer 6:00 PM-7:00 PM: HSD27 – Patient Characteristics and Utilization of Adalimumab-bwwd in the U.S. Department of Veterans Affairs Population Tuesday, May 19, 2026 | Poster Session 4 | 4:00 PM-7:00 PM 6:00 PM-7:00 PM: EE412 – Budget Impact of Introducing Tapinarof, a New Aryl Hydrocarbon Receptor Agonist, for the Treatment of Atopic Dermatitis in Adult and Pediatric Patients from a U.S. Medicaid Plan Perspective 6:00 PM-7:00 PM: SA40 – Real-World Referral Patterns and Healthcare Utilization Among Patients with Headache Disorders in the United Kingdom About NEXPLANON® (etonogestrel implant) 68 mg Radiopaque Indication
NEXPLANON® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years. Selected Safety Information WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications. Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion. Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS. CONTRAINDICATIONS NEXPLANON should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors, benign or malignant, or active liver disease; undiagnosed abnormal uterine bleeding; known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past; and/or allergic reaction to any of the components of NEXPLANON. WARNINGS and PRECAUTIONS
Risk of Complications Due to Improper Insertion and Removal Complications of Insertion and Removal NEXPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert NEXPLANON properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event. Complications related to insertion and removal procedures may occur, e.g., pain, paresthesia, bleeding, hematoma, scarring, or infection. If NEXPLANON is inserted deeply (intramuscular or intrafascial), neural or vascular injury may occur. Postmarketing reports of implants located within the vessels of the arm and the pulmonary artery may have been related to deep insertions or intravascular insertions. Endovascular or surgical procedures may be needed for removal. Implant removal may be difficult or impossible if the implant is not inserted correctly, is inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. If at any time the implant cannot be palpated, it should be localized, and removal is recommended. When an implant is removed, it is important to remove it in its entirety. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event. Broken or Bent Implants Cases of breakage or bending of implants while inserted within a patient’s arm have been reported. Cases of migration of a broken implant fragment within the arm have also occurred. These cases may be related to external forces, e.g., manipulation of the implant or contact sports. The release rate of etonogestrel may be slightly increased in a broken or bent implant, based on in vitro data. NEXPLANON is available only through a restricted program under a REMS. NEXPLANON REMS NEXPLANON is only available through a restricted program under a REMS called NEXPLANON REMS because of the risk of complications due to improper insertion and removal. Notable requirements of the NEXPLANON REMS include the following: Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion and removal of NEXPLANON prior to first use. Pharmacies must be certified with the program and must only dispense NEXPLANON to certified healthcare providers who dispense NEXPLANON for insertion. Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies and certified healthcare providers. Further information is available at www.NEXPLANONREMS.com and 1-833-697-7367. Changes in Menstrual Bleeding Patterns After starting NEXPLANON, women are likely to have changes in their menstrual bleeding pattern. These may include changes in frequency, intensity, or duration. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. In clinical studies of the non-radiopaque etonogestrel implant, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Women should be counseled regarding bleeding pattern changes that they may experience. Ectopic Pregnancies Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain. Thrombotic and Other Vascular Events The use of combination hormonal contraceptives increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is recommended that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed. There have been postmarketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. NEXPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness. Ovarian Cysts If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Rarely, surgery may be required. Carcinoma of the Breast and Reproductive Organs Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer and increase the risk of cervical cancer or intraepithelial neoplasia. Women with a family history of breast cancer or who develop breast nodules should be carefully monitored. Liver Disease NEXPLANON should be removed if jaundice occurs. Elevated Blood Pressure The NEXPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled. Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users. It is not known whether a similar risk exists with progestin-only methods like NEXPLANON. Carbohydrate and Lipid Metabolic Effects Prediabetic and diabetic women using NEXPLANON should be carefully monitored. Depressed Mood Women with a history of depressed mood should be carefully observed. Consideration should be given to removing NEXPLANON in patients who become significantly depressed. Return to Ovulation In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired. Fluid Retention Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. It is unknown if NEXPLANON causes fluid retention. Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. ADVERSE REACTIONS
Clinical Trial Experience The most common adverse reaction causing discontinuation of use of the implant in 3-year clinical trials was change in menstrual bleeding patterns (11.1%). The most common adverse reactions (≥5%) reported in these clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%). In a separate clinical trial to assess contraceptive efficacy and safety of NEXPLANON beyond 3 years, up to 5 years, a similar adverse reaction profile was observed as in Years 1 through 3. The most frequently reported adverse reaction >5% was intermenstrual bleeding (5.4%). Changes in menstrual bleeding patterns were the most frequently reported adverse reaction leading to discontinuation occurring in 4.0% of participants. DRUG INTERACTIONS Effects of Other Drugs on Hormonal Contraceptives Substances decreasing the plasma concentrations of hormonal contraceptives and potentially diminishing the efficacy of hormonal contraceptives: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of hormonal contraceptives and potentially diminish the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Women should use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with hormonal contraceptives, and continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Substances increasing the plasma concentrations of hormonal contraceptives: Co-administration of certain hormonal contraceptives and strong or moderate CYP3A4 inhibitors may increase the serum concentrations of progestins, including etonogestrel. Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors, HCV protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. These changes may be clinically relevant. Effects of Hormonal Contraceptives on Other Drugs Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine). USE IN SPECIFIC POPULATIONS
Pregnancy Rule out pregnancy before inserting NEXPLANON. Lactation Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants. Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Pediatric Use The safety and effectiveness of NEXPLANON have been established in women of reproductive potential. Safety and effectiveness of NEXPLANON are expected to be the same in postpubertal adolescents as in adult women. NEXPLANON is not indicated before menarche. PATIENT COUNSELING INFORMATION Advise women to contact their healthcare professional immediately if, at any time, they are unable to palpate the implant. NEXPLANON does not protect against HIV or other STDs. Before prescribing NEXPLANON, please read the Prescribing Information, including the Boxed Warning. The Patient Information also is available. About VTAMA® (tapinarof) cream, 1% INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for: the topical treatment of plaque psoriasis in adults the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older SELECTED SAFETY INFORMATION Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. Before prescribing VTAMA cream, please read the Prescribing Information. About POHERDY® (pertuzumab-dpzb) INDICATIONS AND USAGE Metastatic Breast Cancer (MBC)
POHERDY is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Early Breast Cancer (EBC)
POHERDY is indicated for use in combination with trastuzumab and chemotherapy for: The neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer The adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence SELECTED SAFETY INFORMATION LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Pertuzumab products can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue POHERDY treatment for a confirmed clinically significant decrease in left ventricular function. Exposure to pertuzumab products can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception. CONTRAINDICATIONS
POHERDY is contraindicated in patients with known hypersensitivity to pertuzumab products or to any of its excipients. WARNINGS AND PRECAUTIONS Left Ventricular Dysfunction
Pertuzumab products can cause left ventricular dysfunction, including symptomatic heart failure. Decreases in LVEF have been reported with drugs that block HER2 activity, including pertuzumab products. Assess LVEF prior to initiation of POHERDY and at regular intervals during treatment to ensure that LVEF is within normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, consider permanent discontinuation of POHERDY and trastuzumab. In the pertuzumab-treated patients with MBC in CLEOPATRA, left ventricular dysfunction occurred in 4% of patients, and symptomatic left ventricular systolic dysfunction (LVSD) (congestive heart failure) occurred in 1% of patients. Patients who received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of decreased LVEF or left ventricular dysfunction. In patients receiving pertuzumab as a neoadjuvant treatment in combination with trastuzumab and docetaxel in NeoSphere, LVEF decline >10% and a drop to 10% and a drop to 30%) with pertuzumab in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting. Before prescribing POHERDY, please read the Prescribing Information, including the Boxed Warning about left ventricular dysfunction and embryo-fetal toxicity. About HADLIMA® (adalimumab-bwwd) Injection INDICATIONS AND USAGE Rheumatoid Arthritis
HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Juvenile Idiopathic Arthritis
HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Psoriatic Arthritis
HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Ankylosing Spondylitis
HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn’s Disease
HADLIMA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis
HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use:
The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers. Plaque Psoriasis
HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa
HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis
HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. SELECTED SAFETY INFORMATION SERIOUS INFECTIONS
Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HADLIMA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients: with chronic or recurrent infection who have been exposed to TB with a history of opportunistic infection who resided in or traveled in regions where mycoses are endemic with underlying conditions that may predispose them to infection Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Do not start HADLIMA during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among adalimumab-treated subjects compared to control subjects. Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated subjects. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. HYPERSENSITIVITY
Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment. Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment. NEUROLOGIC REACTIONS
TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop. HEMATOLOGIC REACTIONS
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping HADLIMA if significant hematologic abnormalities occur. CONGESTIVE HEART FAILURE
Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully. AUTOIMMUNITY
Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome or autoimmune hepatitis. Discontinue treatment if symptoms of a lupus-like syndrome or autoimmune hepatitis develop. IMMUNIZATIONS
Patients on HADLIMA should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS
The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash. Before prescribing HADLIMA, please read the Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are available. About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements
The information above reflects management’s current intentions and expectations for the future with respect to Organon’s expectations regarding milestone expenses, which constitute “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks, assumptions, uncertainties and other factors, such as the completion of Organon’s quarter-end closing process, including review by management and the audit committee of the Organon’s board of directors, which could result in material changes to the preliminary estimates described herein. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings (as amended, where applicable), available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260515139840/en/ Media Contacts: Janine Colavita
(732) 861-3806 Karissa Peer
(614) 314-8094 Investor Contacts: Jennifer Halchak
(201) 275-2711 Renee McKnight
(551) 204-6129 Original: Organon to Present New Research on Access and Value at ISPOR 2026

La Commissione Europea (CE) approva POHERDY® (pertuzumab), messo a punto da Henlius e Organon, il primo biosimilare di PERJETA (pertuzumab) approvato in EuropaApril 30, 2026 1:30 PM
Business Wire
Shanghai Henlius Biotech, Inc. (2696.HK), e Organon (NYSE: OGN) oggi hanno annunciato che la Commissione Europea (CE) ha concesso l'autorizzazione all'immissione in commercio per POHERDY® (pertuzumab) 420 mg/14 mL iniezione per uso endovenoso, il primo e unico biosimilare di PERJETA (pertuzumab) approvato in Europa, per tutte le indicazioni del prodotto di riferimento.1

Questo comunicato stampa include contenuti multimediali. Visualizzare l’intero comunicato qui: https://www.businesswire.com/news/home/20260429169641/it/
“In quanto primo e attualmente unico biosimilare del pertuzumab in Europe, l'approvazione di POHERDY da parte della CE segna un importante traguardo nell'espansione dell'accesso ai trattamenti per pazienti affetti da alcuni tipi di carcinomi mammari HER2 positivi, particolarmente in quanto il tumore al seno è il tipo di cancro più spesso diagnosticato alle donne nell'Unione Europea”, ha dichiarato Joe Azzinaro, Vicepresidente, Global Commercial Lead Biosimilars, presso Organon.2,3 “Il portafoglio globale in espansione di farmaci biosimilari di Organon rafforza il nostro impegno costante per promuovere la sostenibilità dei sistemi sanitari, avanzando al contempo la salute delle donne tramite l'accesso a farmaci di qualità”.3,4


“Partendo dall'approvazione di POHERDY da parte dell’FDA come primo biosimilare del pertuzumab negli Stati Uniti, questa approvazione nell'UE amplia ulteriormente il nostro portafoglio in espansione di farmaci biosimilari approvati in mercati di tutto il mondo e testimonia la nostra solida collaborazione con Organon”, ha dichiarato Ping Cao, Direttore dello sviluppo commerciale e Vicepresidente senior di Henlius. “Guidati dal nostro impegno nell'eccellenza scientifica e nella qualità dei prodotti, stiamo lavorando per ampliare l'accesso alle varie opzioni terapeutiche a vantaggio dei pazienti e del sistema sanitario”.


In Europa, POHERDY è indicato in combinazione con trastuzumab e docetaxel per il trattamento di pazienti adulti con carcinoma mammario HER2 positivo, metastatico o localmente recidivato, non operabile, non trattati in precedenza con terapia anti-HER2 o chemioterapia per la malattia metastatica. POHERDY è anche indicato per l'uso in associazione con trastuzumab e chemioterapia come (i) trattamento neoadiuvante di pazienti adulti con tumore al seno HER2 positivo, localmente avanzato, infiammatorio o in fase precoce ad alto rischio di recidiva e (ii) trattamento adiuvante di pazienti adulti con carcinoma mammario HER2 positivo in fase precoce ad alto rischio di recidiva.


POHERDY è stato approvato sulla base dell'esame di un pacchetto completo di dati, che ha compreso dati analitici strutturali e funzionali, dati clinici di farmacocinetica e studi clinici comparativi a dimostrazione del fatto che POHERDY è un farmaco biologico altamente simile al prodotto di riferimento sulla base della totalità delle prove fornite dai dati analitici, farmacocinetici, di efficacia, sicurezza e immunogenicità (la capacità intrinseca delle proteine e di altri farmaci biologici di generare una risposta immunitaria).5


Nel 2022, Henlius ha stipulato un accordo di licenza e fornitura con Organon, concedendo a Organon i diritti esclusivi di commercializzazione a vari farmaci biosimilari, tra cui POHERDY. L'accordo comprende i diritti di commercializzazione a livello globale, ad eccezione della Cina.6


Informazioni su POHERDY® (pertuzumab) nell'UE

Carcinoma mammario in fase precoce

Poherdy è indicato per l'uso in associazione con trastuzumab e chemioterapia in:



Il trattamento neoadiuvante di pazienti adulti con carcinoma mammario HER2 positivo, localmente avanzato, infiammatorio o in fase precoce ad alto rischio di recidiva



il trattamento adiuvante di pazienti adulti con carcinoma mammario HER2 positivo in fase precoce ad alto rischio di recidiva (vedere sezione 5.1)



Carcinoma mammario metastatico

Poherdy è indicato per l'uso in associazione con trastuzumab e docetaxel in pazienti adulti con carcinoma mammario HER2 positivo, metastatico o localmente recidivato, non operabile, non precedentemente trattati con terapia anti-HER2 o chemioterapia per la malattia metastatica.


Per maggiori informazioni, visitare: Poherdy | Agenzia europea per i medicinali (EMA)


Informazioni su Henlius


Shanghai Henlius Biotech, Inc. (2696.HK) è un'azienda biofarmaceutica globale che si propone di offrire farmaci biologici innovativi di alta qualità, a prezzi ragionevoli per pazienti di tutto il mondo con particolare concentrazione sull'oncologia, le malattie autoimmunitarie e le malattie oculari. Fondata nel 2010, Henlius ha realizzato una piattaforma biofarmaceutica completa, con capacità globali di R&S, attività cliniche, affari normativi, produzione e commercializzazione. La Società impiega quasi 4.000 persone in tutto il mondo ed è attiva in diverse regioni, tra cui Cina, Stati Uniti e Giappone. Sfruttando il suo flusso di cassa stabile generato dal suo portafoglio di prodotti biosimilari a sostegno dell'innovazione, Henlius sta avanzando stabilmente verso la sua fase “Globalisation 2.0”, creando un modello di crescita globale scalabile e sostenibile. All'inizio del 2026, Henlius ha ottenuto approvazioni normative per 10 prodotti in oltre 60 Paesi e regioni in tutto il mondo, comprese sette approvazioni in Cina. La Società ha inoltre raggiunto diversi traguardi nei principali mercati biofarmaceutici, con quattro prodotti approvati dalla Food and Drug Administration (FDA) statunitense e cinque prodotti approvati dalla Commissione Europea (CE), traguardi che riflettono le capacità di R&S, i sistemi di qualità e gli standard di produzione dell'azienda allineati a livello mondiale.


Spinta dall'innovazione, Henlius ha creato un ecosistema tecnologico diversificato e basato su una piattaforma attraverso attività coordinate in R&S a Shanghai, negli Stati Uniti e in altre regioni. Le sue piattaforme di innovazione comprendono inibitori del checkpoint immunitario, tecnologie di interazione con le cellule immunitarie (compresi T cell engager multispecifici), anticorpi coniugati (ADC) e piattaforme di scoperta precoce abilitate all'intelligenza artificiale. La Società attualmente possiede più di 50 prodotti innovativi in fase iniziale, circa il 70% dei quali si prevede siano migliori della categoria, con oltre 30 studi clinici in corso in tutto il mondo. Il prodotto principale di Henlius, serplulimab (nome commerciale: Hetronifly® in Europa), è il primo anti-PD-1 mAb approvato al mondo per il trattamento di prima linea del tumore polmonare a piccole cellule ed è stato approvato in più di 40 mercati a livello globale con un processo accelerato di globalizzazione. In parallelo, una serie di prodotti innovativi ad alto potenziale, tra cui PD-L1 ADC HLX43 e il nuovo epitopo anti-HER2 mAb HLX22, stanno procedendo con lo sviluppo clinico pivotale a livello globale. Supportato da una rete di produzione di farmaci biologici con una capacità totale di 84.000 litri e certificazioni GMP rilasciate da autorità normative in Cina, Europa e Stati Uniti, Henlius rimane incentrata sulla risposta alle esigenze mediche non soddisfatte e alla trasformazione dell'innovazione scientifica in valore clinico significativo e accesso al paziente, contribuendo in modo sostenibile all'ecosistema biofarmaceutico globale.


Per saperne di più su Henlius, visitare https://www.henlius.com/en/index.html e connettersi con l'azienda su LinkedIn all'indirizzo https://www.linkedin.com/company/henlius/.


Informazioni su Organon


Organon (NYSE: OGN) è una società sanitaria globale con la missione di fornire farmaci e soluzioni efficaci per una vita quotidiana più sana. Con un portafoglio di oltre 70 prodotti nei Farmaci generici e per la salute femminile, che comprendono biosimilari, Organon è incentrata sulle esigenze sanitarie che interessano principalmente le donne in modo unico e diversificato, ampliando nel contempo l'accesso ai trattamenti essenziali in oltre 140 mercati.


Con sede a Jersey City, New Jersey, Organon è impegnata a promuovere l'accesso, l'economicità e l'innovazione nell'assistenza sanitaria. Per saperne di più, visitare www.organon.com e seguire l'azienda su LinkedIn, Instagram, X, YouTube, TikTok e Facebook.


Nota cautelativa relativa alle dichiarazioni a carattere previsionale


Il presente comunicato stampa contiene “dichiarazioni previsionali” secondo la definizione indicata nelle disposizioni di salvaguardia della legge statunitense Private Securities Litigation Reform Act del 1995, incluse, a titolo esemplificativo ma non esaustivo, dichiarazioni relative agli obiettivi terapeutici di POHERDY e all'impegno costante di Organon nel supportare la sostenibilità dei sistemi sanitari, promuovendo nel contempo la salute delle donne attraverso l'accesso alla medicina di qualità. Le dichiarazioni previsionali possono essere identificate da termini quali “sarà”, “prevedere”, “in corso”, “impegno a sostenere”, “potrebbe” e termini con analogo significato. Queste dichiarazioni si basano sulle convinzioni e aspettative attuali dell'amministrazione di Organon e sono soggette a notevoli rischi e incertezze. Se le ipotesi sottostanti si rivelassero inesatte o se i rischi o le incertezze dovessero concretizzarsi, i risultati effettivi potrebbero differire sostanzialmente da quelli indicati nelle dichiarazioni previsionali. I fattori che potrebbero determinare la differenza materiale dei risultati rispetto a quelli descritti nelle dichiarazioni previsionali sono riportati nei documenti depositati da Organon presso la SEC, compresa l'ultima Relazione annuale sul Modulo 10-K e altri documenti depositati presso la SEC, disponibili sul sito web della SEC (www.sec.gov). Organon non si assume alcun obbligo di aggiornare pubblicamente alcuna dichiarazione previsionale, sia a seguito di nuove informazioni, eventi futuri o altro.


PERJETA è un marchio commerciale registrato nell'Unione Europea da F. Hoffmann-La Roche AG; Organon non è associata al titolare di questo marchio registrato.




 











1.







PERJETA. Product Information. Genentech, Inc.; 2025.








2.







Breast cancer in the EU. European Commission, Joint Research Centre. Ottobre 2023. Ultimo accesso: 14 aprile 2026. https://ecis.jrc.ec.europa.eu/sites/default/files/2024-01/jrc_Breast_cancer_2022_Oct_2023.pdf








3.







European Medicines Agency and the European Commission. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency (EMA). Ultimo aggiornamento: 29 ottobre 2019. Ultimo accesso: 14 aprile 2026. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf








4.







Troein P, Newton M, Stoddart K, Travaglio M, Arias A. The impact of biosimilar competition in Europe. IQVIA; Gennaio 2025. Ultimo accesso: 14 aprile 2026. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024.pdf








5.







Biosimilar medicines: overview. European Medicines Agency (EMA). 2 aprile 2025. Ultimo accesso: 14 aprile 2026. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview








6.







Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Organon. 13 giugno 2022. Ultimo accesso: 14 aprile 2026. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/







Il testo originale del presente annuncio, redatto nella lingua di partenza, è la versione ufficiale che fa fede. Le traduzioni sono offerte unicamente per comodità del lettore e devono rinviare al testo in lingua originale, che è l'unico giuridicamente valido.

Vedi la versione originale su businesswire.com: https://www.businesswire.com/news/home/20260429169641/it/
Organon - Contatti per i media:


Karissa Peer

(614) 314 8094


Selena Dhanak

+44 (7919) 914475


Organon - Contatti per gli investitori:


Jennifer Halchak

(201) 275-2711


Renee McKnight

(551) 204-6129


Henlius - Contatti per i media:


Janice Han

jiayi_han@henlius.com


Bella Zhou

wenting_zhou@henlius.com


Henlius - Contatti per gli investitori:


Venus Hu

junyan_Hu@henlius.com


Original: La Commissione Europea (CE) approva POHERDY® (pertuzumab), messo a punto da Henlius e Organon, il primo biosimilare di PERJETA (pertuzumab) approvato in Europa

Europäische Kommission erteilt Marktzulassung für POHERDY® (Pertuzumab) von Henlius und Organon, das erste in Europa zugelassene Biosimilar zu PERJETA (Pertuzumab)April 30, 2026 1:30 PM
Business Wire
Shanghai Henlius Biotech, Inc. (2696.HK) und Organon (NYSE: OGN) gaben heute bekannt, dass die Europäische Kommission die Zulassung für POHERDY® (Pertuzumab) 420 mg/14 ml Injektion zur intravenösen Verabreichung erteilt hat. Damit ist POHERDY das erste und einzige in Europa zugelassene Biosimilar zu PERJETA (Pertuzumab) für alle Indikationen des Referenzprodukts.1

Diese Pressemitteilung enthält multimediale Inhalte. Die vollständige Mitteilung hier ansehen: https://www.businesswire.com/news/home/20260429906590/de/
„Als erstes und derzeit einziges Pertuzumab-Biosimilar in Europa stellt die Zulassung von POHERDY durch die Europäische Kommission einen wichtigen Meilenstein bei der Verbesserung des Zugangs zu Therapien für Patientinnen mit bestimmten HER2-positiven Brustkrebserkrankungen dar, zumal Brustkrebs die häufigste Krebsdiagnose bei Frauen in der Europäischen Union ist“, sagte Joe Azzinaro, Vice President und Global Commercial Lead Biosimilars bei Organon.2,3 „Das wachsende globale Portfolio an Biosimilars von Organon untermauert unser langfristiges Engagement für mehr Nachhaltigkeit im Gesundheitswesen und die Förderung der Gesundheit von Frauen durch den Zugang zu hochwertigen Arzneimitteln.“3,4


„Aufbauend auf der FDA-Zulassung von POHERDY in den USA als erstem Pertuzumab-Biosimilar des Landes erweitert die EU-Zulassung unser wachsendes Portfolio an zugelassenen Biosimilar-Arzneimitteln auf Märkten weltweit und zeugt von unserer engen Zusammenarbeit mit Organon“, erklärt Ping Cao, Chief Business Development Officer und Senior Vice President bei Henlius. „Mit unserem Anspruch, wissenschaftliche Exzellenz und eine hohe Produktqualität zu fördern, setzen wir uns dafür ein, den Zugang zu weiteren Behandlungsmöglichkeiten zum Wohl von Patientinnen und Patienten sowie des Gesundheitssystems zu erleichtern.“


In Europa ist POHERDY in Kombination mit Trastuzumab und Docetaxel zur Behandlung von Erwachsenen mit HER2-positivem metastasiertem oder lokal rezidivierendem, inoperablem Brustkrebs indiziert, die noch keine Anti-HER2-Therapie oder Chemotherapie gegen die metastasierte Erkrankung erhalten haben. Außerdem ist POHERDY zur Anwendung in Kombination mit Trastuzumab und einer Chemotherapie indiziert als (i) neoadjuvante Behandlung bei Erwachsenen mit HER2-positivem, lokal fortgeschrittenem, entzündlichem Brustkrebs oder Brustkrebs im Frühstadium mit hohem Rezidivrisiko und (ii) adjuvante Behandlung bei Erwachsenen mit HER2-positivem Brustkrebs im Frühstadium bei hohem Rezidivrisiko.


Die Zulassung von POHERDY wurde nach Prüfung eines umfassenden Datenpakets erteilt, das strukturelle und funktionelle Analysedaten, klinische pharmakokinetische Daten sowie vergleichende klinische Studien umfasste. Diese belegen, dass POHERDY ein biologisches Arzneimittel ist, das dem Referenzprodukt nach allen vorliegenden Erkenntnissen – einschließlich der Daten zu Analyse, Pharmakokinetik, Wirksamkeit, Sicherheit und Immunogenität (die inhärente Fähigkeit von Proteinen und anderen biologischen Arzneimitteln, eine Immunantwort auszulösen) – sehr ähnlich ist.5


Im Jahr 2022 unterzeichnete Henlius einen Lizenz- und Liefervertrag mit Organon, durch den Organon die exklusiven Vermarktungsrechte für mehrere Biosimilars einschließlich POHERDY erhielt. Die Vereinbarung umfasst die weltweiten exklusiven Vermarktungsrechte mit Ausnahme von China.6


Über POHERDY® (Pertuzumab) in der EU

Brustkrebs im Frühstadium

Poherdy ist zur Anwendung in Kombination mit Trastuzumab und einer Chemotherapie indiziert bei:



die neoadjuvante Behandlung erwachsener Patientinnen mit HER2-positivem, lokal fortgeschrittenem, entzündlichem Brustkrebs oder Brustkrebs im Frühstadium mit hohem Rezidivrisiko



die adjuvante Behandlung von erwachsenen Patientinnen mit HER2-positivem Brustkrebs im Frühstadium bei hohem Rezidivrisiko (siehe Abschnitt 5.1)



Metastasierter Brustkrebs

Poherdy ist zur Anwendung in Kombination mit Trastuzumab und Docetaxel bei erwachsenen Patientinnen mit HER2-positivem metastasiertem oder lokal rezidivierendem, inoperablem Brustkrebs indiziert, die zuvor noch keine Anti-HER2-Therapie oder Chemotherapie gegen ihre metastasierte Erkrankung erhalten haben.


Weitere Informationen unter: Poherdy | Europäische Arzneimittel-Agentur (EMA)


Über Henlius


Shanghai Henlius Biotech, Inc. (2696.HK) ist ein weltweit tätiges, innovationsorientiertes biopharmazeutisches Unternehmen mit dem Anspruch, hochwertige und zugleich erschwingliche biologische Therapien für Patientinnen und Patienten weltweit zugänglich zu machen. Der Schwerpunkt des Unternehmens liegt auf wichtigen Therapiebereichen wie Onkologie, Autoimmunerkrankungen und Augenerkrankungen. Henlius wurde 2010 gegründet und hat eine integrierte, biopharmazeutische End-to-End-Plattform aufgebaut, die globale Forschung und Entwicklung, klinische Aktivitäten, regulatorische Angelegenheiten, Produktion und Vermarktung umfasst. Das Unternehmen beschäftigt weltweit fast 4.000 Mitarbeitende und ist in verschiedenen Regionen tätig, darunter China, die USA und Japan. Henlius setzt den stabilen Cashflow aus seinem Biosimilar-Portfolio ein, um seine Innovationskraft zu stärken, und verfolgt auf dem Weg in die Phase „Globalisation 2.0“ ein skalierbares und nachhaltiges globales Wachstumsmodell. Bis zu Beginn des Jahres 2026 erhielt Henlius aufsichtsrechtliche Zulassungen für 10 Produkte in weltweit mehr als 60 Ländern und Regionen, darunter sieben Zulassungen in China. Zudem hat das Unternehmen in wichtigen biopharmazeutischen Märkten zahlreiche Meilensteine erreicht: Vier Produkte wurden von der US-amerikanischen Food and Drug Administration (FDA) und fünf Produkte von der Europäischen Kommission (EK) zugelassen. Dies unterstreicht die weltweit abgestimmten Forschungs- und Entwicklungskapazitäten, Qualitätssysteme und Produktionsstandards des Unternehmens.


Dank seiner innovativen Ausrichtung hat Henlius durch koordinierte Forschungs- und Entwicklungsaktivitäten in Shanghai, den USA und anderen Regionen ein diversifiziertes, plattformbasiertes Technologie-Ökosystem aufgebaut. Zu den Innovationsplattformen des Unternehmens zählen Immun-Checkpoint-Inhibitoren, Technologien zur Bindung an Immunzellen (darunter multispezifische T-Zell-Engager), Antikörper-Wirkstoff-Konjugate (AWKs) sowie KI-gestützte Early-Discovery-Plattformen. Das Unternehmen arbeitet derzeit an mehr als 50 innovativen Wirkstoffen im Frühstadium, davon etwa 70 % Best-in-Class-Wirkstoffe. Weltweit laufen gegenwärtig mehr als 30 klinische Studien. Das Kernprodukt von Henlius – Serplulimab (Handelsname: Hetronifly® in Europa) – ist der weltweit erste Anti-PD-1-mAb, der für die Erstlinienbehandlung von kleinzelligem Lungenkrebs zugelassen wurde und im Rahmen eines beschleunigten Globalisierungsverfahrens in mehr als 40 Märkten verfügbar ist. Parallel dazu befinden sich mehrere vielversprechende innovative Wirkstoffe – darunter der PD-L1-ADC HLX43 und der gegen ein neuartiges Epitop gerichtete Anti-HER2-mAb HLX22 – in der entscheidenden Phase der weltweiten klinischen Entwicklung. Unterstützt durch ein Netzwerk zur Biologika-Herstellung mit einer Gesamtkapazität von 84.000 Litern und GMP-Zertifizierungen von Aufsichtsbehörden in China, Europa und den USA hat Henlius ein stabiles globales Versorgungssystem aufgebaut, das sechs Kontinente versorgt. Henlius verfolgt einen patientenorientierten Ansatz und widmet sich weiterhin dem Ziel, einen ungedeckten medizinischen Bedarf zu decken, mithilfe von wissenschaftlichen Innovationen einen signifikanten klinischen Nutzen zu erzielen und Patienten den Zugang zu diesen Therapien zu erleichtern. So leistet das Unternehmen einen nachhaltigen Beitrag zum globalen biopharmazeutischen Ökosystem.


Um mehr über Henlius zu erfahren, besuchen Sie bitte https://www.henlius.com/en/index.html und verbinden Sie sich mit uns auf LinkedIn unter https://www.linkedin.com/company/henlius/.


Über Organon


Organon (NYSE: OGN) ist ein weltweit tätiges Healthcare-Unternehmen, dessen Mission darin besteht, wirkungsvolle Medikamente und Lösungen für einen gesünderen Alltag anzubieten. Mit einem mehr als 70 Produkte umfassenden Portfolio, das sich auf die Bereiche Frauengesundheit und Allgemeinmedizin erstreckt und auch Biosimilars umfasst, konzentriert sich Organon auf die Deckung von Gesundheitsbedürfnissen, die Frauen in besonderer, überproportionaler oder unterschiedlicher Weise betreffen. Zudem erweitert das Unternehmen den Zugang zu wichtigen Behandlungen in über 140 Märkten.


Organon hat seinen Hauptsitz in Jersey City, New Jersey, und möchte den Zugang, die Erschwinglichkeit und die Innovation im Gesundheitswesen fördern. Weitere Informationen erhalten Sie unter www.organon.com und folgen Sie uns auf LinkedIn, Instagram, X, YouTube, TikTok und Facebook.


Warnhinweis in Bezug auf zukunftsgerichtete Aussagen


Diese Pressemitteilung enthält „zukunftsgerichtete Aussagen“ im Sinne der Safe-Harbor-Bestimmungen des US-amerikanischen Private Securities Litigation Reform Act von 1995, darunter unter anderem Aussagen zu den Therapiezielen von POHERDY sowie zum kontinuierlichen Engagement von Organon, die Nachhaltigkeit der Gesundheitssysteme zu stärken und zugleich die Gesundheit von Frauen durch den Zugang zu hochwertigen Arzneimitteln zu fördern. Zukunftsgerichtete Aussagen können an Begriffen wie „werden“, „planen“, „laufend“, „Engagement für die Unterstützung“, „können“ und ähnlichen Ausdrücken erkennbar sein. Diese Aussagen beruhen auf den gegenwärtigen Einschätzungen und Erwartungen der Geschäftsführung von Organon und unterliegen erheblichen Risiken und Unwägbarkeiten. Sollten sich die zugrunde liegenden Annahmen als unzutreffend erweisen oder Risiken oder Unwägbarkeiten eintreten, können die tatsächlichen Ergebnisse erheblich von den zukunftsgerichteten Aussagen abweichen. Die Faktoren, die dazu führen könnten, dass die tatsächlichen Ergebnisse in wesentlichen Punkten von den in den zukunftsgerichteten Aussagen beschriebenen abweichen, sind in den bei der SEC eingereichten Unterlagen von Organon aufgeführt, darunter der jüngste Jahresbericht von Organon auf Form 10-K sowie weitere bei der SEC eingereichte Unterlagen, die auf der Website der SEC (www.sec.gov) abrufbar sind. Organon verpflichtet sich in keiner Weise zur öffentlichen Aktualisierung zukunftsgerichteter Aussagen aufgrund von neuen Informationen, zukünftigen Ereignissen oder sonstigen Umständen.


PERJETA ist eine von der F. Hoffmann-La Roche AG in der Europäischen Union eingetragene Handelsmarke. Organon ist nicht mit diesem Markeninhaber verbunden.




 











1.







PERJETA. Produktinformation. Genentech, Inc.; 2025.








2.







Breast cancer in the EU. Europäische Kommission, Gemeinsame Forschungsstelle. Oktober 2023. Letzter Zugriff am 14. April 2026. https://ecis.jrc.ec.europa.eu/sites/default/files/2024-01/jrc_Breast_cancer_2022_Oct_2023.pdf








3.







Europäische Arzneimittel-Agentur und Europäische Kommission. Biosimilars in the EU: information guide for healthcare professionals. Europäische Arzneimittel-Agentur (EMA). Zuletzt aktualisiert am 29. Oktober 2019. Letzter Zugriff am 14. April 2026. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf








4.







Troein P, Newton M, Stoddart K, Travaglio M, Arias A. The impact of biosimilar competition in Europe. IQVIA; Januar 2025. Letzter Zugriff am 14. April 2026. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024.pdf








5.







Biosimilar medicines: overview. Europäische Arzneimittel-Agentur (EMA). 2. April 2025. Letzter Zugriff am 14. April 2026. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview








6.







Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Organon. 13. Juni 2022. Letzter Zugriff am 14. April 2026. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/







Die Ausgangssprache, in der der Originaltext veröffentlicht wird, ist die offizielle und autorisierte Version. Übersetzungen werden zur besseren Verständigung mitgeliefert. Nur die Sprachversion, die im Original veröffentlicht wurde, ist rechtsgültig. Gleichen Sie deshalb Übersetzungen mit der originalen Sprachversion der Veröffentlichung ab.

Originalversion auf businesswire.com ansehen: https://www.businesswire.com/news/home/20260429906590/de/
Organon – Medienkontakte:


Karissa Peer

(614) 314 8094


Selena Dhanak

+44 (7919) 914475


Organon – Investorenkontakte:


Jennifer Halchak

(201) 275-2711


Renee McKnight

(551) 204-6129


Henlius – Medienkontakte:


Janice Han

jiayi_han@henlius.com


Bella Zhou

wenting_zhou@henlius.com


Henlius – Investorenkontakt:


Venus Hu

junyan_Hu@henlius.com


Original: Europäische Kommission erteilt Marktzulassung für POHERDY® (Pertuzumab) von Henlius und Organon, das erste in Europa zugelassene Biosimilar zu PERJETA (Pertuzumab)

La Commission européenne (CE) approuve le POHERDY® (pertuzumab) de Henlius et Organon, premier médicament biosimilaire du PERJETA (pertuzumab) autorisé en EuropeApril 30, 2026 11:17 AM
Business Wire
Shanghai Henlius Biotech, Inc. (2696.HK) et Organon (NYSE : OGN) a annoncé aujourd’hui que la Commission européenne (CE) a accordé une autorisation de mise sur le marché pour POHERDY® (pertuzumab) 420 mg/14 ml en solution injectable pour usage intraveineux, le premier et unique médicament biosimilaire de PERJETA (pertuzumab) approuvé en Europe, pour toutes les indications du produit de référence.1

Ce communiqué de presse contient des éléments multimédias. Voir le communiqué complet ici : https://www.businesswire.com/news/home/20260429238590/fr/
« En tant que premier, et actuellement seul, médicament biosimilaire du pertuzumab en Europe, l’autorisation de la CE pour POHERDY marque une étape importante dans l’élargissement de l’accès aux traitements pour les patientes atteintes de certains cancers du sein HER2-positifs, d’autant plus que le cancer du sein est le cancer le plus fréquemment diagnostiqué chez les femmes dans l’Union européenne », déclare Joe Azzinaro, vice-président et responsable commercial mondial des médicaments biosimilaires chez Organon.2,3 « Le portefeuille mondial croissant de médicaments biosimilaires d’Organon renforce notre engagement continu à soutenir la viabilité des systèmes de santé tout en améliorant la santé des femmes grâce à l’accès à des médicaments de qualité. »3,4


« S’appuyant sur l’autorisation de mise sur le marché accordée par la FDA aux États-Unis à POHERDY, premier médicament biosimilaire du pertuzumab dans ce pays, cette autorisation européenne élargit encore notre portefeuille croissant de médicaments biosimilaires approuvés sur les marchés du monde entier et témoigne de notre solide collaboration avec Organon », déclare Ping Cao, directeur du développement commercial et vice-président senior de Henlius. « Guidés par notre engagement en faveur de l’excellence scientifique et de la qualité des produits, nous nous efforçons d’élargir l’accès à des options thérapeutiques supplémentaires dans l’intérêt des patients et du système de santé. »


En Europe, POHERDY est indiqué en association avec le trastuzumab et le docétaxel pour le traitement des adultes atteints d’un cancer du sein HER2-positif métastatique ou localement récidivant inopérable, qui n’ont pas reçu auparavant de traitement anti-HER2 ni de chimiothérapie pour une maladie métastatique. POHERDY est également indiqué en association avec le trastuzumab et une chimiothérapie comme (i) traitement néoadjuvant chez les adultes atteints d’un cancer du sein HER2-positif, localement avancé, inflammatoire ou de stade précoce présentant un risque élevé de récidive et (ii) traitement adjuvant chez les adultes atteints d’un cancer du sein HER2-positif de stade précoce présentant un risque élevé de récidive.


POHERDY a été approuvé sur la base de l’examen d’un dossier complet de données, comprenant des données analytiques structurelles et fonctionnelles, des données pharmacocinétiques cliniques et des études cliniques comparatives démontrant que POHERDY est un médicament biologique hautement similaire au produit de référence sur la base de l’ensemble des preuves, y compris les données analytiques, pharmacocinétiques, d’efficacité, de sécurité et d’immunogénicité (la capacité intrinsèque des protéines et autres médicaments biologiques à provoquer une réponse immunitaire).5


En 2022, Henlius a conclu un accord de licence et d’approvisionnement avec Organon, accordant à Organon les droits exclusifs de commercialisation de plusieurs biosimilaires, dont POHERDY. L’accord couvre les droits exclusifs de commercialisation à l’échelle mondiale, à l’exception de la Chine.6


À propos de POHERDY® (pertuzumab) dans l’UE

Cancer du sein de stade précoce

Poherdy est indiqué en association avec le trastuzumab et une chimiothérapie chez :



le traitement néoadjuvant des patientes adultes atteintes d’un cancer du sein HER2-positif, localement avancé, inflammatoire ou à un stade précoce présentant un risque élevé de récidive



le traitement adjuvant des patientes adultes atteintes d’un cancer du sein HER2-positif à un stade précoce présentant un risque élevé de récidive (voir section 5.1)



Cancer du sein métastatique

Poherdy est indiqué en association avec le trastuzumab et le docétaxel chez les patients adultes atteints d’un cancer du sein HER2-positif métastatique ou localement récidivant non résécable, qui n’ont pas reçu de traitement anti-HER2 ni de chimiothérapie antérieurs pour leur maladie métastatique.


Pour plus d’informations, rendez-vous sur : Poherdy | Agence européenne des médicaments (EMA)


À propos de Henlius


Shanghai Henlius Biotech, Inc. (2696.HK) est une société biopharmaceutique internationale axée sur l’innovation, qui s’engage à fournir des traitements biologiques de haute qualité et abordables aux patients du monde entier. La société se concentre sur des domaines thérapeutiques majeurs, notamment l’oncologie, les maladies auto-immunes et les maladies ophtalmiques. Fondée en 2010, Henlius a mis en place une plateforme biopharmaceutique intégrée de bout en bout, englobant la R&D mondiale, les opérations cliniques, les affaires réglementaires, la fabrication et la commercialisation. La société emploie près de 4 000 personnes à travers le monde et opère dans plusieurs régions, notamment en Chine, aux États-Unis et au Japon. S’appuyant sur les flux de trésorerie stables générés par son portefeuille de biosimilaires pour soutenir l’innovation, Henlius progresse régulièrement vers sa phase de « Globalisation 2.0 », en construisant un modèle de croissance mondial évolutif et durable. Début 2026, Henlius avait obtenu des autorisations réglementaires pour 10 produits dans plus de 60 pays et régions à travers le monde, dont sept autorisations en Chine. La société a également franchi de nombreuses étapes importantes sur les principaux marchés biopharmaceutiques, avec quatre produits approuvés par la Food and Drug Administration (FDA) américaine et cinq produits approuvés par la Commission européenne (CE), ce qui reflète ses capacités de R&D, ses systèmes de qualité et ses normes de fabrication harmonisés à l’échelle mondiale.


Animée par l’innovation, Henlius a mis en place un écosystème technologique diversifié et basé sur des plateformes grâce à des efforts de R&D coordonnés à Shanghai, aux États-Unis et dans d’autres régions. Ses plateformes d’innovation couvrent les inhibiteurs de points de contrôle immunitaires, les technologies d’engagement des cellules immunitaires (y compris les engageurs de cellules T multispécifiques), les conjugués anticorps-médicaments (ADC) et les plateformes de découverte précoce basées sur l’IA. La société dispose actuellement de plus de 50 actifs innovants en phase précoce, dont environ 70 % devraient être les meilleurs de leur catégorie, avec plus de 30 essais cliniques en cours à l’échelle mondiale. Le produit phare de Henlius, le serplulimab (nom commercial : Hetronifly® en Europe), est le premier anticorps monoclonal anti-PD-1 au monde approuvé pour le traitement de première intention du cancer du poumon à petites cellules, et il a été approuvé sur plus de 40 marchés à travers le monde et bénéficie d’un processus de mondialisation accéléré. Parallèlement, plusieurs actifs innovants à fort potentiel (notamment l’ADC PD-L1 HLX43 et le nouvel anticorps monoclonal anti-HER2 à épitope HLX22) progressent dans le cadre de développements cliniques pivots à l’échelle mondiale. S’appuyant sur un réseau de fabrication de produits biologiques d’une capacité totale de 84 000 litres et sur des certifications GMP délivrées par les autorités réglementaires en Chine, en Europe et aux États-Unis, Henlius a mis en place un système d’approvisionnement mondial stable desservant six continents. Guidée par une mission centrée sur le patient, Henlius reste déterminée à répondre aux besoins médicaux non satisfaits et à traduire l’innovation scientifique en valeur clinique significative et en accès pour les patients, contribuant ainsi de manière durable à l’écosystème biopharmaceutique mondial.


Pour en savoir plus sur Henlius, rendez-vous sur https://www.henlius.com/en/index.html et rejoignez-nous sur LinkedIn à l’adresse https://www.linkedin.com/company/henlius/.


À propos d'Organon


Organon (NYSE : OGN) est une entreprise mondiale de soins de santé dont la mission est de fournir des médicaments et des solutions efficaces pour une vie quotidienne plus saine. Avec un portefeuille de plus de 70 produits dans les domaines de la santé féminine et des médicaments généraux, y compris des biosimilaires, Organon se concentre sur les besoins de santé qui touchent de manière unique, disproportionnée ou différente les femmes, tout en élargissant l’accès aux traitements essentiels dans plus de 140 marchés.


Basée à Jersey City, dans le New Jersey, Organon s’engage à améliorer l’accès, l’abordabilité et l’innovation dans le domaine des soins de santé. Pour en savoir plus, rendez-vous sur www.organon.com et suivez-nous sur LinkedIn, Instagram, X, YouTube, TikTok et Facebook.


Mise en garde concernant les déclarations prospectives


Le présent communiqué de presse contient des « déclarations prospectives » au sens des dispositions de l’U.S. Private Securities Litigation Reform Act de 1995, y compris, sans s’y limiter, des déclarations concernant les objectifs thérapeutiques de POHERDY et l’engagement continu d’Organon à soutenir la viabilité des systèmes de santé tout en faisant progresser la santé des femmes grâce à l’accès à des médicaments de qualité. Les déclarations prospectives peuvent être identifiées par des mots tels que « sera », « prévoit », « en cours », « engagement à soutenir », « pourrait » et des mots de sens similaire. Ces déclarations sont fondées sur les convictions et les attentes actuelles de la direction d’Organon et sont soumises à des risques et incertitudes importants. Si les hypothèses sous-jacentes s’avèrent inexactes ou si des risques ou des incertitudes se matérialisent, les résultats réels peuvent différer matériellement de ceux énoncés dans les déclarations prospectives. Des facteurs susceptibles d’entraîner des résultats sensiblement différents de ceux décrits dans les déclarations prospectives figurent dans les documents déposés par Organon auprès de la SEC, y compris le rapport annuel d’Organon sur formulaire 10-K le plus récent et les autres documents déposés auprès de la SEC, disponibles sur le site Internet de la SEC (www.sec.gov). Organon ne s’engage pas à mettre à jour publiquement les déclarations prévisionnelles, que ce soit à la suite de nouvelles informations, d’événements futurs ou autres.


PERJETA est une marque déposée dans l’Union européenne par F. Hoffmann-La Roche AG ; Organon n’est pas associée au titulaire de cette marque.




 











1.







PERJETA. Informations produit. Genentech, Inc. ; 2025.








2.







Breast cancer in the EU. European Commission, Joint Research Centre. Octobre 2023. Consulté le 14 avril 2026. https://ecis.jrc.ec.europa.eu/sites/default/files/2024-01/jrc_Breast_cancer_2022_Oct_2023.pdf








3.







European Medicines Agency and the European Commission. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency (EMA). Dernière mise à jour le 29 octobre 2019. Consulté le 14 avril 2026. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf








4.







Troein P, Newton M, Stoddart K, Travaglio M, Arias A. The impact of biosimilar competition in Europe. IQVIA ; Janvier 2025. Consulté le 14 avril 2026. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024.pdf








5.







Biosimilar medicines: overview. European Medicines Agency (EMA). 2 avril 2025. Consulté le 14 avril 2026. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview








6.







Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Organon. 13 juin 2022. Consulté le 14 avril 2026. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/







Le texte du communiqué issu d’une traduction ne doit d’aucune manière être considéré comme officiel. La seule version du communiqué qui fasse foi est celle du communiqué dans sa langue d’origine. La traduction devra toujours être confrontée au texte source, qui fera jurisprudence.

Consultez la version source sur businesswire.com : https://www.businesswire.com/news/home/20260429238590/fr/
Contact médias Organon :


Karissa Peer

(614) 314 8094


Selena Dhanak

+44 (7919) 914475


Contact investisseurs Organon :


Jennifer Halchak

(201) 275-2711


Renee McKnight

(551) 204-6129


Contact médias Henlius :


Janice Han

jiayi_han@henlius.com


Bella Zhou

wenting_zhou@henlius.com


Contact investisseurs Henlius :


Venus Hu

junyan_Hu@henlius.com


Original: La Commission européenne (CE) approuve le POHERDY® (pertuzumab) de Henlius et Organon, premier médicament biosimilaire du PERJETA (pertuzumab) autorisé en Europe

Organon Reports Results for the First Quarter Ended March 31, 2026April 30, 2026 7:30 AM
Business Wire

First quarter 2026 revenue of $1.460 billion, down 4% as-reported and down 9% excluding the impact of foreign currency.



First quarter 2026 diluted earnings per share of $0.55 and non-GAAP Adjusted diluted earnings per share of $0.71.



First quarter 2026 net income of $146 million and Adjusted EBITDA (non-GAAP) of $415 million, representing an Adjusted EBITDA margin of 28.4%.



On April 26, 2026, the company announced its pending merger into Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”) in an all-cash transaction (the “merger”). The merger is expected to close in early 2027, subject to customary closing conditions, including receipt of required regulatory approvals and approval by Organon stockholders.



In light of the pending merger, Organon will not be providing financial guidance or hosting quarterly earnings calls.



Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2026.


First Quarter 2026 Revenue




in $ millions






 






Q1 2026






 






Q1 2025






 






VPY






 






VPY ex-FX








Women’s Health






 






$






389






 






$






463






 






(16)%






 






(19)%








General Medicines






 






 






 






 






 






 






 






 








Biosimilars






 






 






173






 






 






141






 






23%






 






21%








Established Brands






 






 






880






 






 






887






 






(1)%






 






(7)%








Other (1)






 






 






18






 






 






22






 






(15)%






 






(21)%








Revenue






 






$






1,460






 






$






1,513






 






(4)%






 






(9)%







 









 



Totals may not foot due to rounding and percentages are computed using unrounded amounts.








(1) Other includes manufacturing sales to third parties.







For the first quarter of 2026, total revenue was $1.460 billion, down 4% on an as-reported basis and down 9% excluding the impact of foreign currency (ex-FX), compared with the first quarter of 2025.


Women’s Health revenue declined 16% as-reported and declined 19% ex-FX in the first quarter of 2026, compared with the first quarter of 2025.



Sales of Nexplanon® (etonogestrel implant) decreased 21% ex-FX in the first quarter compared with the first quarter of 2025. In the U.S., sales of Nexplanon declined 28% primarily due to both decreased physician demand following the five-year label approval which as expected, has delayed reinsertions; and continued uncertainty around federal funding. Outside of the U.S., Nexplanon sales declined 4% ex-FX, due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil.



Sales of oral contraceptives MarvelonTM (desogestrel and ethinyl estradiol pill) and MercilonTM (desogestrel and ethinyl estradiol pill) declined 36% ex-FX in the first quarter of 2026 primarily due to decreased demand and market contraction in China and the timing of shipments in Asia Pacific.



Global Fertility revenue was down 9% ex-FX as a result of competition-driven price reductions in the U.S. partially offset by modest market growth in China.



In January of 2026 the company completed the sale of the Jada® system to Laborie.



Biosimilars revenue increased 23% as-reported and 21% ex-FX in the first quarter of 2026, compared with the first quarter of 2025, primarily due to the strong performance of Hadlima® (adalimumab-bwwd) associated with stronger demand in the U.S., and increased demand in Puerto Rico. Biosimilars also benefitted from contribution from new assets, Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp) which were approved by the U.S. Food and Drug Administration (“FDA”) in the third quarter of 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025.


Established Brands revenue declined 1% as-reported and declined 7% ex-FX in the first quarter of 2026. Revenue contribution from Emgality®(1) (galcanezumab-gnlm) partially offset a decline in the respiratory portfolio, which was driven by pricing pressure, as well as volume declines related to the adoption of revised medical guidelines that deprioritize the use of montelukast, including Singulair® (montelukast sodium), in various international markets, most recently, in China. Global sales of Dulera® (mometasone furoate and formoterol fumarate dihydrate) also declined in the first quarter of 2026 primarily due to pricing pressure and decreased demand in the U.S. VTAMA® (tapinarof) grew modestly in the first quarter of 2026 compared with the first quarter of 2025.


(1) Organon acquired certain European licensing and distribution rights to Emgality from Eli Lilly and Company (“Eli Lilly”) beginning in early 2024. Emgality is a registered trademark of Eli Lilly in the European Union and other countries (used under license).


First Quarter 2026 Profitability




in $ millions, except per share amounts






 






Q1 2026






 






Q1 2025






 






VPY








Revenues






 






$






1,460






 






$






1,513






 






(4)%








Cost of sales






 






 






677






 






 






672






 






1%








Gross profit






 






 






783






 






 






841






 






(7)%








Non-GAAP Adjusted gross profit (1)






 






 






861






 






 






934






 






(8)%








Net income






 






 






146






 






 






87






 






68%








Non-GAAP Adjusted net income (1)






 






 






188






 






 






265






 






(29)%








Diluted Earnings per Share (EPS)






 






 






0.55






 






 






0.33






 






67%








Non-GAAP Adjusted diluted EPS (1)






 






 






0.71






 






 






1.02






 






(30)%








Acquired in-process research & development (IPR&D) and milestones






 






 






—






 






 






6






 






NM








Adjusted EBITDA (Non-GAAP) (1)






 






 






415






 






 






484






 






(14)%








 






 






 






 






 






 






 








 






 






Q1 2026






 






Q1 2025






 






 








Gross margin






 






 






53.6 %






 






 






55.6 %






 






 








Non-GAAP Adjusted gross margin (1)






 






 






59.0 %






 






 






61.7 %






 






 








Adjusted EBITDA margin (Non-GAAP) (1, 2)






 






 






28.4 %






 






 






32.0 %






 






 







 







 



(1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures.







Reported gross margin in the first quarter of 2026 was 53.6% compared with 55.6% in the prior year period. Non-GAAP Adjusted gross margin was 59.0% in the first quarter of 2026, compared to 61.7% in the first quarter of 2025. Unfavorable pricing and product mix as well as foreign exchange rates were notable drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin.


Net income for the first quarter of 2026 was $146 million, or $0.55 per diluted share, compared with net income of $87 million, or $0.33 per diluted share, in the first quarter of 2025. For the first quarter of 2026, non-GAAP Adjusted net income was $188 million, or $0.71 per diluted share, compared with $265 million, or $1.02 per diluted share, for the first quarter of 2025.


Non-GAAP Adjusted EBITDA margin was 28.4% in the first quarter of 2026 compared with 32.0% in the first quarter of 2025. The year-over-year decline was primarily driven by a decrease in Adjusted Gross Margin.


Capital Allocation

Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. The dividend is payable on June 11, 2026, to stockholders of record at the close of business on May 11, 2026.


As of March 31, 2026, cash and cash equivalents were $1.12 billion, and debt was $8.57 billion.


Webcast Information

As is customary during the pendency of an acquisition, Organon has suspended its quarterly earnings calls and will not host a conference call in conjunction with today’s first quarter earnings release.


About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.


Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.


Cautionary Note Regarding Non-GAAP Financial Measures

This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles (“GAAP”). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, Adjusted EPS, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures.


The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations.


Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the merger, including the anticipated timing of completion thereof. Forward-looking statements may be identified by words such as “proposed,” “will,” “continue,” “expects,” “believes,” “estimates,” “opportunity,” “pursue,” “anticipate,” “be able to,” “intend,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.


Risks and uncertainties include, but are not limited to uncertainties as to the timing of the merger; the risk that the merger may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the merger, including receiving, on a timely basis or otherwise, the minimum vote required by Organon’s stockholders to approve the merger; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the various conditions to the consummation of the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances which would require Organon to pay a termination fee; the effect of the announcement or pendency of the merger on Organon’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally; risks related to diverting management’s attention from Organon’s ongoing business operations; the risk that stockholder litigation in connection with the merger may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the merger that may impact Organon’s ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the merger could have adverse effects on the market price of Organon’s common stock, including if the merger is not consummated; risks that the benefits of the merger are not realized when and as expected; and legislative, regulatory and economic developments.


The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K, Current Report on Form 8-K, filed by the company on April 27, 2026, and other SEC filings, available at the SEC’s Internet site (www.sec.gov).


Additional Information and Where to Find It

This press release may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, Organon intends to file relevant materials with the SEC, including Organon’s proxy statement in preliminary and definitive form on Schedule 14A (the “Merger Proxy Statement”). Organon will mail the Merger Proxy Statement and a proxy card to its stockholders in connection with the merger.


INVESTORS AND STOCKHOLDERS OF ORGANON ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE MERGER PROXY STATEMENT (WHEN THEY ARE AVAILABLE), BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ORGANON, SUN PHARMA AND THE MERGER AND RELATED MATTERS. Investors and stockholders of Organon are or will be able to obtain these documents (when they are available) free of charge from the SEC’s website at www.sec.gov, or through the investor relations section of Organon’s website, https://www.organon.com.


Participants in the Solicitation


Organon and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be “participants” in the solicitation of proxies from stockholders of Organon in favor of the proposed acquisition. Information about Organon’s directors and executive officers is set forth in the 2026 Annual Meeting Proxy Statement, filed with the SEC on April 24, 2026, and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/0001821825/000119312526177411/ogn-20260423.htm. To the extent holdings of Organon’s securities by its directors or executive officers have changed since the amounts set forth in the 2026 Annual Meeting Proxy Statement, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC, which are available at https://www.sec.gov/edgar/browse/?CIK=1821825. Additional information concerning the interests of Organon’s participants in the solicitation, which may, in some cases, be different than those of Organon’s stockholders generally, will be set forth in the Merger Proxy Statement when it becomes available. 



TABLE 1 


 



Organon & Co.








Condensed Consolidated Statement of Income








(Unaudited, $ in millions except shares in thousands and per share amounts)







 



 






Three Months Ended

March 31,








 






2026






 






2025








Revenues






$






1,460






 






 






$






1,513






 








Cost of sales






 






677






 






 






 






672






 








Gross Profit






 






783






 






 






 






841






 








 






 






 






 








Selling, general and administrative






 






424






 






 






 






420






 








Research and development






 






93






 






 






 






96






 








Acquired in-process research and development and milestones






 






—






 






 






 






6






 








Restructuring costs






 






31






 






 






 






86






 








Interest expense






 






111






 






 






 






124






 








Exchange losses (gains)






 






7






 






 






 






(4






)








Other (income) expense, net






 






(96






)






 






 






12






 








Income before income taxes






 






213






 






 






 






101






 








Income tax expense






 






67






 






 






 






14






 








Net income






$






146






 






 






$






87






 








 






 






 






 








Earnings per share:






 






 






 








Basic






$






0.56






 






 






$






0.34






 








Diluted






$






0.55






 






 






$






0.33






 








 






 






 






 








Weighted average shares outstanding:






 






 






 








Basic






 






260,370






 






 






 






257,862






 








Diluted






 






262,896






 






 






 






261,001






 








TABLE 2 


 



Organon & Co.








Sales by top products








(Unaudited, $ in millions)







 



 






Three Months Ended March 31,








 






2026






 






2025








($ in millions)






U.S.






 






Int’l






 






Total






 






U.S.






 






Int’l






 






Total








Women’s Health






 






 






 






 






 






 






 






 






 






 






 








Nexplanon/Implanon NXT






$






127






 






$






74






 






$






201






 






$






176






 






$






72






 






$






248








Follistim AQ






 






21






 






 






39






 






 






61






 






 






35






 






 






34






 






 






69








NuvaRing






 






6






 






 






18






 






 






24






 






 






6






 






 






16






 






 






22








Ganirelix Acetate Injection






 






2






 






 






24






 






 






26






 






 






5






 






 






23






 






 






27








Marvelon/Mercilon






 






—






 






 






26






 






 






26






 






 






—






 






 






39






 






 






39








Jada






 






5






 






 






—






 






 






5






 






 






15






 






 






—






 






 






15








Other Women’s Health (1)






 






17






 






 






30






 






 






46






 






 






15






 






 






27






 






 






43








General Medicines






 






 






 






 






 






 






 






 






 






 






 








Biosimilars






 






 






 






 






 






 






 






 






 






 






 








Renflexis






 






42






 






 






15






 






 






57






 






 






44






 






 






12






 






 






57








Hadlima






 






51






 






 






16






 






 






67






 






 






33






 






 






14






 






 






47








Ontruzant






 






4






 






 






1






 






 






5






 






 






4






 






 






14






 






 






18








Brenzys






 






—






 






 






20






 






 






20






 






 






—






 






 






14






 






 






14








Other Biosimilars (1)






 






11






 






 






13






 






 






24






 






 






—






 






 






5






 






 






5








Established Brands






 






 






 






 






 






 






 






 






 






 






 








Cardiovascular






 






 






 






 






 






 






 






 






 






 






 








Atozet






 






—






 






 






85






 






 






85






 






 






—






 






 






77






 






 






77








Zetia






 






1






 






 






86






 






 






87






 






 






1






 






 






84






 






 






85








Cozaar/Hyzaar






 






2






 






 






55






 






 






57






 






 






2






 






 






53






 






 






55








Vytorin






 






1






 






 






20






 






 






21






 






 






1






 






 






22






 






 






23








Rosuzet






 






—






 






 






6






 






 






6






 






 






—






 






 






4






 






 






4








Other Cardiovascular (1)






 






1






 






 






27






 






 






28






 






 






—






 






 






30






 






 






30








Respiratory






 






 






 






 






 






 






 






 






 






 






 








Singulair






 






2






 






 






38






 






 






40






 






 






2






 






 






72






 






 






74








Nasonex






 






—






 






 






65






 






 






65






 






 






—






 






 






71






 






 






72








Dulera






 






23






 






 






12






 






 






35






 






 






34






 






 






10






 






 






43








Clarinex






 






1






 






 






30






 






 






31






 






 






—






 






 






34






 






 






34








Other Respiratory (1)






 






11






 






 






1






 






 






12






 






 






10






 






 






3






 






 






13








Non-Opioid Pain, Bone and Dermatology






 






 






 






 






 






 






 






 






 






 






 








Arcoxia






 






—






 






 






59






 






 






59






 






 






—






 






 






62






 






 






62








Fosamax






 






—






 






 






29






 






 






29






 






 






1






 






 






32






 






 






33








Diprospan






 






—






 






 






35






 






 






35






 






 






—






 






 






30






 






 






30








Vtama






 






23






 






 






2






 






 






25






 






 






20






 






 






4






 






 






24








Other Non-Opioid Pain, Bone and Dermatology (1)






 






3






 






 






65






 






 






68






 






 






4






 






 






65






 






 






68








Other






 






 






 






 






 






 






 






 






 






 






 








Propecia






 






1






 






 






28






 






 






30






 






 






1






 






 






24






 






 






26








Emgality






 






—






 






 






54






 






 






54






 






 






—






 






 






32






 






 






32








Proscar






 






—






 






 






26






 






 






26






 






 






—






 






 






24






 






 






24








Other (1)






 






3






 






 






85






 






 






87






 






 






3






 






 






76






 






 






78








Other (2)






 






—






 






 






18






 






 






18






 






 






—






 






 






22






 






 






22








Revenues






$






358






 






$






1,102






 






$






1,460






 






$






412






 






$






1,101






 






$






1,513







 



Totals may not foot due to rounding. Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies.








(1) Includes sales of products not listed separately.








(2) Other includes manufacturing sales to third parties.








TABLE 3 


 



Organon & Co.








Sales by geographic area








(Unaudited, $ in millions)







 



 






Three Months Ended

March 31,








 






2026






 






2025








Europe and Canada






$






412






 






$






376








United States






 






358






 






 






412








Asia Pacific and Japan






 






226






 






 






251








China






 






194






 






 






204








Latin America, Middle East, Russia, and Africa






 






247






 






 






240








Other (1)






 






23






 






 






30








Revenues






$






1,460






 






$






1,513







 



(1) Other includes manufacturing sales to third parties.








TABLE 4 


 



Organon & Co.








Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics








(Unaudited, $ in millions)








 








 






Three Months Ended

March 31,








 






2026






 






2025








GAAP Gross Profit






$






783






 






 






$






841






 








Adjusted for:






 






 






 








Manufacturing network costs (1)






 






21






 






 






 






29






 








Stock-based compensation






 






3






 






 






 






4






 








Amortization






 






47






 






 






 






50






 








Acquisition-related costs (2)






 






7






 






 






 






9






 








Other






 






—






 






 






 






1






 








Adjusted Non-GAAP Gross Profit






$






861






 






 






$






934






 








 






 






 






 








(1) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5.








(2) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5.








 






 






 






 








 






Three Months Ended

March 31,








 






2026






 






2025








GAAP Gross Margin






 






53.6






%






 






 






55.6






%








Total impact of Non-GAAP adjustments






 






5.4






%






 






 






6.1






%








Adjusted Non-GAAP Gross Margin






 






59.0






%






 






 






61.7






%








 






 






 






 








 






Three Months Ended

March 31,








 






2026






 






2025








GAAP Selling, general and administrative expenses






$






424






 






 






$






420






 








Adjusted for:






 






 






 








Stock-based compensation






 






(13






)






 






 






(16






)








Restructuring related charges






 






—






 






 






 






(6






)








Other






 






(13






)






 






 






(3






)








Adjusted Non-GAAP Selling, general and administrative expenses






$






398






 






 






$






395






 








TABLE 4 


 



Organon & Co.








Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued)








(Unaudited, $ in millions except per share amounts)








 








 






Three Months Ended

March 31,








 






2026






 






2025








GAAP Research and development expenses






$






93






 






 






$






96






 








Adjusted for:






 






 






 








Manufacturing network costs (1)






 






(3






)






 






 






(3






)








Stock-based compensation






 






(3






)






 






 






(4






)








Other






 






(1






)






 






 






(1






)








Adjusted Non-GAAP Research and development expenses






$






86






 






 






$






88






 








 






 






 






 








(1) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5.








 






 






 






 








 






Three Months Ended

March 31,








 






2026






 






2025








GAAP Reported Net Income






$






146






 






 






$






87






 








Adjusted for:






 






 






 








Cost of sales adjustments






 






78






 






 






 






93






 








Selling, general and administrative adjustments






 






26






 






 






 






25






 








Research and development adjustments






 






7






 






 






 






8






 








Jada divestiture






 






(81






)






 






 






—






 








Restructuring






 






31






 






 






 






86






 








Change in fair value of contingent consideration






 






(5






)






 






 






11






 








Other (gain) expense, net






 






(3






)






 






 






4






 








Tax impact on adjustments above(1)






 






(11






)






 






 






(49






)








Non-GAAP Adjusted Net Income






$






188






 






 






$






265






 








 






 






 






 








(1) For the three months ended March 31, 2026 and 2025, the GAAP income tax rates were 31.4% and 13.4%, respectively, and the non-GAAP income tax rates were 29.3% and 19.2%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments.








 






 






 






 








 






Three Months Ended

March 31,








 






2026






 






2025








GAAP Diluted Earnings per Share






$






0.55






 






 






$






0.33






 








Total impact of Non-GAAP adjustments






 






0.16






 






 






 






0.69






 








Non-GAAP Adjusted Diluted Earnings per Share






$






0.71






 






 






$






1.02






 








TABLE 5


 



Organon & Co.








Reconciliation of GAAP Net (Loss) Income to Non-GAAP Adjusted EBITDA








(Unaudited, $ in millions)







 



 






Three Months Ended

March 31,








 






2026






 






2025








GAAP Reported Net Income






$






146






 






 






$






87






 








Depreciation (1)






 






38






 






 






 






32






 








Amortization






 






47






 






 






 






50






 








Interest expense






 






111






 






 






 






124






 








Income tax expense (benefit)






 






67






 






 






 






14






 








EBITDA (Non-GAAP)






$






409






 






 






$






307






 








Restructuring and related charges






 






31






 






 






 






92






 








Manufacturing network related (2)






 






27






 






 






 






36






 








Acquisition-related costs (3)






 






7






 






 






 






9






 








Change in contingent consideration






 






(5






)






 






 






11






 








Jada divestiture






 






(81






)






 






 






—






 








Other costs






 






8






 






 






 






5






 








Stock-based compensation






 






19






 






 






 






24






 








Adjusted EBITDA (Non-GAAP)






$






415






 






 






$






484






 








Adjusted EBITDA margin (Non-GAAP)






 






28.4






%






 






 






32.0






%








 






 






 






 








(1) Excludes accelerated depreciation included in one-time costs.








(2) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs.








(3) Acquisition related costs for the three months ended March 31, 2026 and 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction.








As the costs described in (1) through (3) above are directly related to the separation of Organon and acquisition related activities and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance.







 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260430180575/en/
Media Contacts:
Felicia Bisaro

(646) 703-1807
Kate Vossen

(732) 675-8448
Investor Contacts:
Jennifer Halchak

(201) 275-2711
Renee McKnight

(551) 204-6129


Original: Organon Reports Results for the First Quarter Ended March 31, 2026