USFDAJun 8, 2026, 04:01 AM
Alvotech: FDA Accepts BLA for AVT16, Entyvio Biosimilar
AI Summary
Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for AVT16. AVT16 is a proposed interchangeable biosimilar to Entyvio® (vedolizumab) for intravenous administration, developed in partnership with Teva Pharmaceutical Industries Ltd. The BLA submission is supported by comprehensive analytical, pharmacokinetic, and immunogenicity data. If approved, AVT16 would expand biosimilar options in the U.S. for treating moderately to severely active ulcerative colitis and Crohn’s disease.
Key Highlights
- FDA accepted Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio.
- AVT16 is for intravenous administration, targeting ulcerative colitis and Crohn’s disease.
- Alvotech is partnered with Teva Pharmaceutical Industries Ltd. for AVT16 commercialization.
- BLA submission is supported by comprehensive analytical, pharmacokinetic, and immunogenicity data.
- Alvotech announced positive pivotal pharmacokinetic study results for AVT80 (subcutaneous Entyvio biosimilar) in February 2026.
- European Medicines Agency validated Marketing Authorization Application for both AVT16 and AVT80.
- Alvotech has five biosimilars approved and marketed globally, with nine disclosed candidates in pipeline.
Price Impact
More from ALVO