TRUXIMA is also now available for the treatment
of Granulomatosis with Polyangiitis (GPA) (Wegener’s
Granulomatosis) and Microscopic Polyangiitis (MPA)
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Celltrion
Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that
TRUXIMA® (rituximab-abbs) injection is now available in the United
States for the treatment of:
- Rheumatoid Arthritis (RA) in combination with methotrexate in
adult patients with moderately-to severely-active RA who have
inadequate response to one or more TNF antagonist therapies
- Granulomatosis with Polyangiitis (GPA) (Wegener’s
Granulomatosis) and Microscopic Polyangiitis (MPA) in adult
patients in combination with glucocorticoids
TRUXIMA is the only biosimilar to the reference product
Rituxan®1 (rituximab) available to treat rheumatoid arthritis in
the United States. See important safety information below including
Boxed Warning regarding fatal infusion-related reactions, severe
mucocutaneous reactions, hepatitis B virus reactivation and
progressive multifocal leukoencephalopathy.
“We are proud to make TRUXIMA available to patients and
providers as a treatment option for these indications, especially
as this is the only rituximab biosimilar indicated for rheumatoid
arthritis,” said Brendan O’Grady, Executive Vice President, North
America Commercial, Teva. “Following the launch of our other
biosimilar earlier this year, we remain focused on our commitment
to lower healthcare costs and increase price competition through
the availability of biosimilars.”
Celltrion Healthcare and Teva Pharmaceutical Industries Ltd.
entered into an exclusive partnership in October 2016 for Teva to
commercialize TRUXIMA in the U.S. and Canada. In May 2019, TRUXIMA
was approved by the U.S. Food and Drug Administration (FDA) to
match all of the reference product’s oncology indications described
below.
“We are pleased that patients in the United States can now have
access to TRUXIMA for these new indications,” said Mr. Hyoung-Ki
Kim, Vice Chairman at Celltrion Healthcare. “We believe that the
continued use of biosimilars in the U.S. market will contribute to
addressing unmet needs for patients and providers.”
Earlier this year, the Centers for Medicare and Medicaid
Services (CMS) granted pass-through status for TRUXIMA in the
hospital outpatient setting. The Wholesale Acquisition Cost (WAC or
“list price”) for TRUXIMA will be 10 percent lower than the
reference product. TRUXIMA is expected to be available through
primary wholesalers at a WAC of $845.55 per 100mg vial and
$4,227.75 per 500mg vial. Actual costs to individual patients and
providers for TRUXIMA are anticipated to be lower than WAC because
WAC does not account for additional rebates and discounts that may
apply. Savings on out-of-pocket costs may vary depending on the
patient’s insurance payer and eligibility for participation in the
assistance program.
Teva also offers dedicated patient support services through the
CORE program. CORE is available to help eligible patients,
caregivers and healthcare professionals navigate the reimbursement
process. CORE offers a range of services, including benefits
verification and coverage determination, support for
precertification and prior authorization, assistance with coverage
guidelines and claims investigation, and support through the claims
and appeals process. A savings program is also available for
eligible commercially insured patients. To learn more, please visit
TevaCORE.com.
Please see the Important Safety Information below including the
Boxed Warning regarding fatal infusion-related reactions, severe
mucocutaneous reactions, hepatitis B virus reactivation and
progressive multifocal leukoencephalopathy. For more information,
please see the full prescribing information.
Indications TRUXIMA (rituximab-abbs) is indicated for the
treatment of adult patients with:
Non-Hodgkin’s Lymphoma (NHL)
- Relapsed or refractory, low-grade or follicular, CD20-positive,
B-cell NHL as a single agent
- Previously untreated follicular, CD20-positive, B-cell NHL in
combination with first-line chemotherapy and, in patients achieving
a complete or partial response to a rituximab product in
combination with chemotherapy, as single-agent maintenance
therapy
- Non-progressing (including stable disease), low-grade,
CD20-positive, B-cell NHL as a single agent after first-line
cyclophosphamide, vincristine, and prednisone (CVP)
chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in
combination with cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) or other anthracycline-based chemotherapy
regimens
Chronic Lymphocytic Leukemia (CLL)
- In combination with fludarabine and cyclophosphamide (FC), for
the treatment of adult patients with previously untreated and
previously treated CD20-positive CLL
Rheumatoid Arthritis (RA)
- In combination with methotrexate, for the treatment of adult
patients with moderately to severely active RA who have had an
inadequate response to one or more tumor necrosis factor (TNF)
antagonist therapies
Granulomatosis with Polyangiitis (GPA) (Wegener’s
Granulomatosis) and Microscopic Polyangiitis (MPA)
- In combination with glucocorticoids, for the treatment of adult
patients with GPA and MPA
Important Safety Information
WARNING: FATAL
INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS,
HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL
LEUKOENCEPHALOPATHY
Infusion-Related Reactions: Administration of rituximab
products, including TRUXIMA, can result in serious, including
fatal, infusion-related reactions. Deaths within 24 hours of
rituximab infusion have occurred. Approximately 80% of fatal
infusion-related reactions occurred in association with the first
infusion. Monitor patients closely. Discontinue TRUXIMA infusion
for severe reactions and provide medical treatment for Grade 3 or 4
infusion-related reactions
Severe Mucocutaneous Reactions: Severe, including fatal,
mucocutaneous reactions can occur in patients receiving rituximab
products
Hepatitis B Virus (HBV) Reactivation: HBV reactivation can
occur in patients treated with rituximab products, in some cases
resulting in fulminant hepatitis, hepatic failure, and death.
Screen all patients for HBV infection before treatment initiation,
and monitor patients during and after treatment with TRUXIMA.
Discontinue TRUXIMA and concomitant medications in the event of HBV
reactivation
Progressive Multifocal Leukoencephalopathy (PML),
including fatal PML, can occur in patients receiving rituximab
products
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions - Rituximab products can cause
severe, including fatal, infusion-related reactions. Severe
reactions typically occurred during the first infusion with time to
onset of 30-120 minutes. Rituximab product-induced infusion-related
reactions and sequelae include urticaria, hypotension, angioedema,
hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory
distress syndrome, myocardial infarction, ventricular fibrillation,
cardiogenic shock, anaphylactoid events, or death
Premedicate patients with an antihistamine and acetaminophen
prior to dosing. For RA, GPA, and MPA patients, methylprednisolone
100 mg intravenously or its equivalent is recommended 30 minutes
prior to each infusion. Institute medical management (e.g.
glucocorticoids, epinephrine, bronchodilators, or oxygen) for
infusion-related reactions as needed. Depending on the severity of
the infusion-related reaction and the required interventions,
temporarily or permanently discontinue TRUXIMA. Resume infusion at
a minimum 50% reduction in rate after symptoms have resolved.
Closely monitor the following patients: those with pre-existing
cardiac or pulmonary conditions, those who experienced prior
cardiopulmonary adverse reactions, and those with high numbers of
circulating malignant cells (≥25,000/mm3)
Severe Mucocutaneous Reactions - Mucocutaneous reactions,
some with fatal outcome, can occur in patients treated with
rituximab products. These reactions include paraneoplastic
pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis,
vesiculobullous dermatitis, and toxic epidermal necrolysis. The
onset of these reactions has been variable and includes reports
with onset on the first day of rituximab exposure. Discontinue
TRUXIMA in patients who experience a severe mucocutaneous reaction.
The safety of re-administration of rituximab products to patients
with severe mucocutaneous reactions has not been determined
Hepatitis B Virus Reactivation - Hepatitis B virus (HBV)
reactivation, in some cases resulting in fulminant hepatitis,
hepatic failure and death, can occur in patients treated with drugs
classified as CD20-directed cytolytic antibodies, including
rituximab products. Cases have been reported in patients who are
hepatitis B surface antigen (HBsAg) positive and also in patients
who are HBsAg negative but are hepatitis B core antibody (anti-HBc)
positive. Reactivation also has occurred in patients who appear to
have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc
positive and hepatitis B surface antibody [anti-HBs] positive)
HBV reactivation is defined as an abrupt increase in HBV
replication manifesting as a rapid increase in serum HBV DNA levels
or detection of HBsAg in a person who was previously HBsAg negative
and anti-HBc positive. Reactivation of HBV replication is often
followed by hepatitis, i.e., increase in transaminase levels. In
severe cases increase in bilirubin levels, liver failure, and death
can occur
Screen all patients for HBV infection by measuring HBsAg and
anti-HBc before initiating treatment with TRUXIMA. For patients who
show evidence of prior hepatitis B infection (HBsAg positive
[regardless of antibody status] or HBsAg negative but anti-HBc
positive), consult with physicians with expertise in managing
hepatitis B regarding monitoring and consideration for HBV
antiviral therapy before and/or during TRUXIMA treatment
Monitor patients with evidence of current or prior HBV infection
for clinical and laboratory signs of hepatitis or HBV reactivation
during and for several months following TRUXIMA therapy. HBV
reactivation has been reported up to 24 months following completion
of rituximab therapy
In patients who develop reactivation of HBV while on TRUXIMA,
immediately discontinue TRUXIMA and any concomitant chemotherapy,
and institute appropriate treatment. Insufficient data exist
regarding the safety of resuming TRUXIMA treatment in patients who
develop HBV reactivation. Resumption of TRUXIMA treatment in
patients whose HBV reactivation resolves should be discussed with
physicians with expertise in managing HBV
Progressive Multifocal Leukoencephalopathy (PML) - JC
virus infection resulting in PML and death can occur in rituximab
product-treated patients with hematologic malignancies. The
majority of patients with hematologic malignancies diagnosed with
PML received rituximab in combination with chemotherapy or as part
of a hematopoietic stem cell transplant. Most cases of PML were
diagnosed within 12 months of their last infusion of rituximab
Consider the diagnosis of PML in any patient presenting with
new-onset neurologic manifestations. Evaluation of PML includes,
but is not limited to, consultation with a neurologist, brain MRI,
and lumbar puncture
Discontinue TRUXIMA and consider discontinuation or reduction of
any concomitant chemotherapy or immunosuppressive therapy in
patients who develop PML
Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia,
hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis,
sometimes fatal, can occur within 12-24 hours after the first
infusion of rituximab products in patients with NHL. A high number
of circulating malignant cells ( ≥25,000/mm3) or high tumor burden, confers a
greater risk of TLS
Administer aggressive intravenous hydration and
anti-hyperuricemic therapy in patients at high risk for TLS.
Correct electrolyte abnormalities, monitor renal function and fluid
balance, and administer supportive care, including dialysis as
indicated
Infections - Serious, including fatal, bacterial, fungal,
and new or reactivated viral infections can occur during and
following the completion of rituximab product-based therapy.
Infections have been reported in some patients with prolonged
hypogammaglobulinemia (defined as hypogammaglobulinemia >11
months after rituximab exposure). New or reactivated viral
infections included cytomegalovirus, herpes simplex virus,
parvovirus B19, varicella zoster virus, West Nile virus, and
hepatitis B and C. Discontinue TRUXIMA for serious infections and
institute appropriate anti-infective therapy. TRUXIMA is not
recommended for use in patients with severe, active infections
Cardiovascular Adverse Reactions - Cardiac adverse reactions, including
ventricular fibrillation, myocardial infarction, and cardiogenic
shock may occur in patients receiving rituximab products.
Discontinue infusions for serious or life-threatening cardiac
arrhythmias. Perform cardiac monitoring during and after all
infusions of TRUXIMA for patients who develop clinically
significant arrhythmias, or who have a history of arrhythmia or
angina
Renal Toxicity - Severe, including fatal, renal toxicity can
occur after rituximab product administration in patients with NHL.
Renal toxicity has occurred in patients who experience tumor lysis
syndrome and in patients with NHL administered concomitant
cisplatin therapy during clinical trials. The combination of
cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs
of renal failure and discontinue TRUXIMA in patients with a rising
serum creatinine or oliguria
Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and
perforation, in some cases leading to death, can occur in patients
receiving rituximab in combination with chemotherapy. In
postmarketing reports, the mean time to documented gastrointestinal
perforation was 6 (range 1-77) days in patients with NHL. Evaluate
if symptoms of obstruction such as abdominal pain or repeated
vomiting occur
Immunization - The
safety of immunization with live viral vaccines following rituximab
product therapy has not been studied and vaccination with live
virus vaccines is not recommended before or during
treatment
Prior to initiating TRUXIMA
physicians should ensure patients’ vaccinations and immunizations
are up-to-date with guidelines. Administration of any non-live
vaccines should occur at least 4 weeks prior to a course of
TRUXIMA
Embryo-Fetal Toxicity - Based on human data, rituximab products can
cause fetal harm due to B-cell lymphocytopenia in infants exposed
to rituximab in-utero. Advise pregnant women of the risk to a
fetus. Females of childbearing potential should use effective
contraception while receiving TRUXIMA and for 12 months following
the last dose of TRUXIMA
Concomitant Use With Other Biologic Agents and DMARDS Other
Than Methotrexate
Observe patients closely for
signs of infection if biologic agents and/or DMARDs are used
concomitantly as limited safety data is
available.
Use of concomitant
immunosuppressants other than corticosteroids has not been studied
in GPA or MPA patients exhibiting peripheral B-cell depletion
following treatment with rituximab products
Use in RA Patients Who Have Not Had Prior Inadequate Response
to TNF Antagonists
TRUXIMA should only be used in
patients who have had a prior inadequate response to one or more
TNF antagonist
Most common adverse reactions in clinical trials of NHL
(≥25%) were: infusion-related reactions, fever,
lymphopenia, chills, infection, and asthenia
Most common adverse reactions in clinical trials of CLL
(≥25%) were: infusion-related reactions and
neutropenia
Most common adverse reactions in clinical trials of RA
(≥10%) were:
upper respiratory tract infection, nasopharyngitis, urinary tract
infection, and bronchitis (other important adverse reactions
include infusion-related reactions, serious infections, and
cardiovascular events)
Most common adverse reactions in clinical trials of GPA and
MPA (≥15%) were:
infections, nausea, diarrhea, headache, muscle spasms, anemia,
peripheral edema, and infusion-related reactions
Nursing Mothers - There are no data on the presence of
rituximab in human milk, the effect on the breastfed child, or the
effect on milk production. Since many drugs including antibodies
are present in human milk, advise a lactating woman not to
breastfeed during treatment and for at least 6 months after the
last dose of TRUXIMA due to the potential for serious adverse
reactions in breastfed infants
About TRUXIMA® TRUXIMA (rituximab-abbs) is a U.S. Food
and Drug Administration (FDA)-approved biosimilar to RITUXAN®
(rituximab) for the treatment of: adult patients with
CD20-positive, B-cell NHL to be used as a single agent or in
combination with chemotherapy or CLL in combination with
fludarabine and cyclophosphamide (FC); for rheumatoid arthritis
(RA) in combination with methotrexate in adult patients with
moderately-to severely-active RA who have inadequate response to
one or more TNF antagonist therapies; and granulomatosis with
polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic
polyangiitis (MPA) in adult patients in combination with
glucocorticoids
TRUXIMA has the same mechanism of action as Rituxan and has
demonstrated biosimilarity to Rituxan through a totality of
evidence.
About Celltrion Healthcare, Co. Ltd. Celltrion Healthcare
conducts the worldwide marketing, sales and distribution of
biological medicines developed by Celltrion, Inc. through an
extensive global network that spans more than 120 different
countries. Celltrion Healthcare’s products are manufactured at
state-of-the-art mammalian cell culture facilities, designed and
built to comply with the US Food and Drug Administration (FDA) cGMP
guidelines and the EU GMP guidelines.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) has been developing and producing medicines to improve
people’s lives for more than a century. We are a global leader in
generic and specialty medicines with a portfolio consisting of over
3,500 products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Teva's Cautionary Note Regarding Forward-Looking
Statements This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 regarding the launch of TRUXIMA Injection for
Rheumatoid Arthritis in the United States, which are based on
management’s current beliefs and expectations and are subject to
substantial risks and uncertainties, both known and unknown, that
could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
- the commercial success of TRUXIMA;
- our ability to successfully compete in the marketplace;
consolidation of our customer base and commercial alliances among
our customers; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; competition for our
specialty products, especially COPAXONE®, our leading medicine,
which faces competition from existing and potential additional
generic versions, competing glatiramer acetate products and
orally-administered alternatives; the uncertainty of commercial
success AJOVY® and AUSTEDO® ; competition from companies with
greater resources and capabilities; delays in launches of new
products and our ability to achieve expected results from
investments in our product pipeline; ability to develop and
commercialize biopharmaceutical products; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations and the effectiveness of our patents
and other measures to protect our intellectual property
rights;
- our business and operations in general, including:
implementation of our restructuring plan announced in December
2017; our ability to attract, hire and retain highly skilled
personnel; our ability to develop and commercialize additional
pharmaceutical products; compliance with anti-corruption, sanctions
and trade control laws; manufacturing or quality control problems;
interruptions in our supply chain including due to potential
effects of the COVID-19 outbreak on our operations in geographic
locations impacted by the outbreak and on the business operations
of our customers and suppliers; disruptions of information
technology systems; breaches of our data security; variations in
intellectual property laws; challenges associated with conducting
business globally, including adverse effects of political or
economic instability, major hostilities or terrorism; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; our prospects and
opportunities for growth if we sell assets and potential
difficulties related to the operation of our new global enterprise
resource planning (ERP) system;
- compliance, regulatory and litigation matters, including:
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications in the U.S. and our
ability to reach a final resolution of the remaining opioid-related
litigation; costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into S&M practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2019, including in the sections
captioned "Risk Factors” and “Forward Looking Statements.”
Forward-looking statements speak only as of the date on which they
are made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
1 RITUXAN is a registered trademark of Genentech and Biogen.
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