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Alvotech announced that the U.S. Food and Drug Administration has accepted for review a Biologics License Application…
ALVOAlvotech
Alvotech announced that the U.S. Food and Drug Administration has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector formats for subcutaneous administration. This submission complements the BLA for AVT16, an intravenous presentation accepted in May 2026, covering both delivery methods under a partnership with Teva Pharmaceutical Industries Ltd., which handles commercialization. The filing supports Alvotech's broader immunology pipeline aimed at expanding access to biologic medicines for ulcerative colitis and Crohn's disease. Alvotech is a biotechnology company specializing in the development and manufacture of biosimilar medicines.