AVT80 (biosimilar to Entyvio) - (AVT80-GL-P01)

Aug. 31, 2026: Alvotech (NASDAQ: ALVO, ALVO-SDB) said the FDA accepted for review a BLA for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector formulations for subcutaneous use. Entyvio is approved for adults with moderately to severely active ulcerative colitis and Crohn’s disease. Alvotech is developing and manufacturing AVT80 under a partnership in which Teva (NYSE/TASE: TEVA) will commercialize it.

The filing is supported by analytical, pharmacokinetic, and immunogenicity data. Alvotech said AVT80 was submitted as a proposed interchangeable biosimilar.

Related vedolizumab program milestones: in February 2026, Alvotech reported positive results from a pivotal randomized, double-blind, single-dose, parallel-group, three-arm pharmacokinetic study of AVT80 versus Entyvio in healthy adults; the study met all primary endpoints and, based on regulatory advice, is considered pivotal for demonstrating clinical similarity for both AVT80 and AVT16. In May 2026, the FDA accepted for review the BLA for AVT16, Alvotech’s proposed interchangeable intravenous vedolizumab biosimilar. The company also said the EMA has validated an MAA covering both AVT16 and AVT80.