USFDAJun 8, 2026, 04:37 PM
Alvotech Announces FDA Acceptance of BLA for AVT16 Biosimilar
AI Summary
Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab). This marks a significant step in Alvotech's mission to increase access to biologic medicines. The company also reported its first-quarter 2026 financial results, with total revenues of $105.9 million and adjusted EBITDA of $24.4 million. Alvotech provided an outlook for 2026, anticipating total revenues between $650-$700 million.
Key Highlights
- Alvotech announced FDA acceptance of Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio®.
- AVT16 is developed and manufactured by Alvotech under a partnership with Teva Pharmaceutical Industries Ltd., who handles commercialization.
- The BLA submission is supported by a comprehensive data package demonstrating biosimilarity.
- If approved, AVT16 could be substituted for Entyvio® at the pharmacy without prescriber intervention.
- Alvotech reported Q1 2026 revenues of $105.9 million, a decrease from $132.8 million in Q1 2025.
- Adjusted EBITDA for Q1 2026 was $24.4 million with a Gross Margin of 57%.
- The company anticipates 2026 total revenues to be in the range of $650-$700 million and adjusted EBITDA of $180-220 million.
Price Impact
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