Alvontech (ALVO)

Alvotech shares jump after FDA accepts Entyvio biosimilar application for review (ALVO)June 8, 2026 6:41 AM
IH Market News Alvotech (NASDAQ:ALVO) shares climbed 12% in premarket trading on Thursday after the biotechnology company announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for AVT16, an interchangeable biosimilar candidate to Entyvio. The regulatory development represents an important step forward for Alvotech as it advances plans to compete in the market for biosimilar versions of the inflammatory bowel disease treatment. FDA review advances AVT16 toward potential approval According to the company, AVT16 is being developed as an interchangeable biosimilar to Entyvio, a biologic medicine widely used to treat inflammatory bowel diseases. FDA acceptance of the application means the agency will now proceed with a formal review of the product, moving Alvotech closer to a potential commercial launch in the United States. The Iceland-based biopharmaceutical group said that, if approved, AVT16 could be substituted for Entyvio at pharmacies without prescriber intervention. Interchangeable status could broaden market opportunity An interchangeable biosimilar designation carries significant commercial advantages in the U.S. market, as it allows pharmacists to replace the reference product with the biosimilar without requiring approval from the prescribing physician. Such a designation could help accelerate adoption of AVT16 and improve patient access while creating a larger market opportunity for Alvotech. The FDA’s decision to accept the application marks a key regulatory milestone as the company continues to expand its biosimilars portfolio and pursue additional growth opportunities in major global healthcare markets. Alvotech stock price Original: Alvotech shares jump after FDA accepts Entyvio biosimilar application for review (ALVO)

Alvotech Advances Entyvio Biosimilar Program Following Successful Clinical StudyFebruary 5, 2026 6:21 AM
IH Market News
Alvotech (NASDAQ:ALVO) reported positive findings from a pharmacokinetic trial evaluating AVT80, its experimental biosimilar to Entyvio, after the study successfully achieved all primary objectives. The randomized, double-blind trial compared AVT80 with Entyvio in healthy adult volunteers who received a single 108 mg subcutaneous dose.The research examined pharmacokinetics, safety, tolerability and immunogenic response of AVT80 relative to the reference product. Based on the outcome, the company said the data supports continued progress toward regulatory filing for the biosimilar candidate.Alvotech is currently developing two potential biosimilars to Entyvio: AVT16, designed for intravenous delivery, and AVT80, intended for subcutaneous use. The company noted that the study demonstrates pharmacokinetic comparability for both delivery formats and represents a key milestone in confirming clinical similarity for the two programs.Entyvio, produced by Takeda, is used to treat adult patients with moderate-to-severe ulcerative colitis and Crohn’s disease. According to company information, the treatment generated around $6.4 billion in global net sales during 2025.Headquartered in Iceland, Alvotech focuses on the development and production of biosimilar therapies. The company has already secured regulatory approvals for two biosimilars referencing Humira and Stelara across several international markets.Both AVT16 and AVT80 contain vedolizumab, a human monoclonal antibody designed to target the alpha-4-beta-7 protein found on T helper lymphocytes. The two treatments remain under investigation and have not yet been approved by regulatory authorities in any jurisdiction.Alvotech stock price

Original: Alvotech Advances Entyvio Biosimilar Program Following Successful Clinical Study

The name has not been fixed yet?

ALVO new 52 week high

ALVO new 52 week high

ALVO new 52=week high

Alvotech Provides Regulatory Update on AVT02 Biologics License Application
April 13 2023 - 08:45PM
GlobeNewswire Inc

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA’s reinspection of the company’s Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved. No other deficiencies in the application were noted by the FDA. Alvotech provided the FDA comprehensive responses to the inspection observations on April 3, 2023, and is awaiting communication from the agency assessing those responses.
Alvotech’s second BLA for AVT02, which contains data to support approval as a biosimilar and additional information supporting potential interchangeability designation – remains under review by the FDA, with a Biosimilar User Fee Amendment (BsUFA) goal date of June 28, 2023. Satisfactory outcome of the facility reinspection remains the key requirement for approval.

“We look forward to working with the FDA to resolve any outstanding issues identified in the reinspection,” said Robert Wessman, Chairman and CEO of Alvotech. “We are committed to manufacturing AVT02 for patients in the United States, especially a potentially differentiated Humira biosimilar that provides a high-concentration formulation and is interchangeable.”

About AVT02
AVT02 is a monoclonal antibody and has been approved as a biosimilar to Humira® (adalimumab) in the 27 EU member countries, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia and Saudi Arabia. It is currently marketed in sixteen countries in Europe and in Canada. Dossiers are under review in multiple countries, including in the United States.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

Just to be clear the company name is ALVOTECH not alvoNtech which was an error while creating the board. I will fix it asap. The stock symbol is ALVO

Alvotech

https://www.alvotech.com/

We have a deep appreciation for the positive impact biologic medicines have had on health care. From insulin to vaccines to monoclonal antibody cancer therapies, biologic medicines are revolutionizing the way we treat diseases and improve patient lives.

It is our aim to broaden the availability of these important biologic medicines to patients around the world by developing and manufacturing high-quality, cost-competitive biosimilars.

Our commitment to the promise of biosimilars is foundational to our approach, our culture and the strong sense of purpose that inspires us to work smarter and faster towards this mission.

We are driven by passion - if there is a proven biologic medicine, we believe it should be accessible to all patients in need.