Alvotech (ALVO), a biotechnology company, announced that its Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for intravenous administration, has been accepted for review by the FDA.
According to the company, the Biologics License Application submission is supported by a comprehensive data package and immunogenicity data that demonstrated biosimilarity between AVT16 and its reference product.
AVT16 is an investigational humanized monoclonal antibody which is being formulated as a lyophilized vial that has been validated for marketing authorization application by the European Medicines Agency or EMA along with another compound AVT80 (pre-filled syringe and auto-injector).
AVT16's proposed biosimilar vedolizumab is an integrin receptor antagonist that binds to a specific alpha-4 beta-7 integrin, which is involved in the migration of certain white blood cells into gastrointestinal tissue. It is used in the treatment of adults with ulcerative colitis and Crohn's disease.
In the U.S., an interchangeable biosimilar may be substituted for its reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws.
The company stated that AVT16 is one of their disclosed biosimilar candidates in immunology and is part of a broader pipeline aimed at expanding access to biologic medicines in major therapeutic areas.
Additionally, in February 2026 AVT80 another proposed biosimilar to Entyvio reported positive results from a pivotal pharmacokinetic study for subcutaneous administration. Alvotech will be responsible for development and manufacture of AVT16 while its partner Teva Pharmaceutical will take hold of commercialization, noted the firm.
Alvotech is currently trading at $3.99, up 12.71%.
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