Reykjavik, Iceland – August 31, 2026
Alvotech announced that the U.S. FDA has accepted for review its Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) for subcutaneous administration. AVT80 is being developed as both a prefilled syringe and autoinjector, expanding Alvotech’s vedolizumab biosimilar program beyond intravenous administration. The application is being developed in partnership with Teva Pharmaceutical Industries, with Alvotech responsible for development and manufacturing and Teva responsible for commercialization. The FDA acceptance represents an important regulatory milestone for the program and follows the agency’s acceptance of Alvotech’s BLA for AVT16, its proposed interchangeable vedolizumab biosimilar for intravenous administration, in May 2026. Together, AVT80 and AVT16 are designed to provide biosimilar options covering multiple presentations of the Entyvio reference product.
Alvotech Advances Subcutaneous Entyvio Biosimilar
The FDA review acceptance positions AVT80 for regulatory evaluation as a proposed interchangeable biosimilar to Entyvio for subcutaneous use. The candidate is specifically designed for administration through a prefilled syringe or autoinjector, potentially broadening the available delivery options for patients with moderately to severely active ulcerative colitis and Crohn’s disease. Alvotech said the BLA is supported by a comprehensive package of analytical, pharmacokinetic and immunogenicity data intended to demonstrate biosimilarity to the reference product. The company previously reported positive results from a pivotal pharmacokinetic study in February 2026. That randomized, double-blind, single-dose, three-arm study compared AVT80 with Entyvio in healthy adult participants and met all primary endpoints. Based on regulatory advice, the study is considered pivotal for supporting clinical similarity for both AVT80 and AVT16.
AVT80 Complements Alvotech’s AVT16 Program
Alvotech’s broader vedolizumab biosimilar program now includes both subcutaneous and intravenous formulations. AVT16 is being developed as an interchangeable biosimilar to Entyvio for intravenous administration, while AVT80 is being developed as a prefilled syringe and autoinjector for subcutaneous administration. The company said European regulatory progress also covers both candidates, with the European Medicines Agency having validated a Marketing Authorization Application covering AVT16 and AVT80. Entyvio is a humanized monoclonal antibody that targets the alpha-4-beta-7 integrin, a pathway involved in the migration of certain white blood cells into gastrointestinal tissue. By developing multiple presentations, Alvotech is seeking to expand its biosimilar offering across an established immunology treatment while supporting additional administration options for patients and healthcare providers..
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Alvotech Expands Global Biosimilar Pipeline
The FDA acceptance for AVT80 adds another regulatory milestone to Alvotech’s broader biosimilar development strategy, which is focused on increasing access to biologic medicines across major therapeutic areas. The company has multiple biosimilar candidates targeting autoimmune disorders, eye disorders and cancer, supported by an integrated development and manufacturing model. Alvotech has also established commercial partnerships intended to extend the reach of its biosimilar products across the United States, Europe, Japan, China and other international markets. However, AVT80 remains investigational, and regulatory authorities have not yet established its biosimilarity or interchangeability with Entyvio. The FDA’s acceptance of the BLA means the application has entered regulatory review; it does not represent an approval. If ultimately approved, AVT80 could add a subcutaneous biosimilar option to the U.S. vedolizumab market, complementing the company’s intravenous AVT16 program and further advancing Alvotech’s immunology-focused biosimilar portfolio.
Source:Alvotech,press relese
