AVT16 - (Entyvio biosimilar)

June 8, 2026: Alvotech (NASDAQ: ALVO; ALVO-SDB) announced the FDA has accepted for review its Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) as a lyophilized vial for intravenous administration, for the reference indications of moderately to severely active ulcerative colitis and Crohn’s disease in adults. Under its partnership with Teva Pharmaceutical Industries Ltd. (NYSE/TASE: TEVA), Alvotech will handle development and manufacturing, while Teva will commercialize AVT16.

The BLA is supported by analytical, pharmacokinetic, and immunogenicity data intended to demonstrate biosimilarity versus the reference product. The submission seeks “interchangeable” status, which, if approved, could allow pharmacy-level substitution subject to applicable laws.

Additional related program update: Alvotech cited February 2026 positive results from a pivotal pharmacokinetic study of AVT80 (a proposed subcutaneous biosimilar to Entyvio) that met all primary endpoints; based on regulatory advice, this study is considered pivotal to support clinical similarity for both AVT16 and AVT80. In the EU, EMA has validated an MAA covering AVT16 and AVT80.