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FDA accepts Alvotech's application for AVT16, a biosimilar to Entyvio, advancing treatment options for inflammatory diseases.

Market News
08 Jun 2026
GlobeNewsWire
View Source
Bullish
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Alvotech announced that the FDA has accepted its Biologics License Application for AVT16, an interchangeable biosimilar to Entyvio (vedolizumab), used to treat ulcerative colitis and Crohn’s disease. This acceptance marks a key step toward expanding patient access to biologic treatments in the U.S. AVT16 is developed and manufactured by Alvotech, with commercialization by Teva Pharmaceutical. If approved, AVT16 could be substituted for Entyvio at pharmacies without prescriber intervention, potentially lowering costs and increasing treatment options. The application is supported by comprehensive data demonstrating biosimilarity, and Alvotech is also developing AVT80, a related biosimilar for subcutaneous use.

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