REYKJAVIK, Iceland, June 8, 2026
Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) for intravenous administration. The regulatory milestone advances Alvotech’s efforts to expand patient access to biologic therapies and marks another important step in the company’s growing biosimilar portfolio. Under its partnership agreement, Alvotech is responsible for the development and manufacturing of AVT16, while Teva Pharmaceutical Industries Ltd. will lead commercialization activities in the United States.
FDA Review Advances Interchangeable Biosimilar Program
The FDA acceptance is supported by a comprehensive package of analytical, pharmacokinetic, and immunogenicity data designed to demonstrate biosimilarity between AVT16 and the reference biologic product, Entyvio. AVT16 has been submitted as a proposed interchangeable biosimilar, a designation that, if granted, could allow pharmacists to substitute the product for the reference medicine without intervention from the prescribing physician, subject to state pharmacy regulations. Entyvio is widely used for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, making it an important target for biosimilar development aimed at improving affordability and access.
Expanding Access to Treatments for Inflammatory Bowel Disease
Vedolizumab, the active ingredient in Entyvio, is a monoclonal antibody that selectively targets the alpha-4-beta-7 integrin, helping reduce inflammation by preventing specific white blood cells from migrating into gastrointestinal tissue. If approved, AVT16 would provide healthcare providers and patients with an additional treatment option for inflammatory bowel diseases while potentially lowering healthcare costs through biosimilar competition. The candidate forms part of Alvotech’s broader immunology pipeline, which focuses on developing high-quality biosimilars for major chronic diseases affecting patients worldwide.
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Building a Global Biosimilar Portfolio
The AVT16 submission follows positive results reported earlier this year for AVT80, Alvotech’s proposed subcutaneous biosimilar to Entyvio. According to the company, a pivotal pharmacokinetic study met all primary endpoints and is expected to support regulatory filings for both AVT16 and AVT80. Alvotech has established itself as a major biosimilar developer, with approved products referencing blockbuster biologics including Humira®, Stelara®, Simponi®, Eylea®, and Prolia®/Xgeva®. The company’s development pipeline currently includes multiple biosimilar candidates targeting autoimmune diseases, oncology, respiratory disorders, eye diseases, and osteoporosis. With the FDA now reviewing AVT16, Alvotech continues to strengthen its position as a global leader in biosimilar medicines while pursuing its mission of expanding access to advanced biologic treatments.
Source: Alvotech press release
