USFDAJun 8, 2026, 04:01 AM
Alvotech's AVT16 Biosimilar BLA Accepted by FDA
AI Summary
Alvotech announced that the U.S. FDA has accepted for review its Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) for intravenous administration. This development, in partnership with Teva Pharmaceutical Industries Ltd. for commercialization, marks a significant step in expanding access to biologic medicines for patients with ulcerative colitis and Crohn’s disease. The BLA is supported by comprehensive data, and if approved, AVT16 could be substituted for the reference product at the pharmacy level.
Key Highlights
- FDA accepted Biologics License Application (BLA) for Alvotech's AVT16.
- AVT16 is a proposed interchangeable biosimilar to Entyvio® (vedolizumab).
- Alvotech partners with Teva Pharmaceutical Industries Ltd. for AVT16 commercialization.
- BLA supported by comprehensive analytical, pharmacokinetic, and immunogenicity data.
- AVT16 targets moderately to severely active ulcerative colitis and Crohn’s disease.
- European Medicines Agency (EMA) validated Marketing Authorization Application for AVT16 and AVT80.
- Positive results for AVT80 (subcutaneous Entyvio biosimilar) pivotal study announced in February 2026.
Price Impact
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