Alvotech's Application for Proposed Entyvio Biosimilar Accepted for US FDA Review

MT Newswires · 2d ago
05:37 AM EDT, 08/31/2026 (MT Newswires) -- Alvotech (ALVO.IC, ALVO-SDB.ST) said Monday its application for AVT80, a proposed interchangeable biosimilar to Entyvio, was accepted for review by the US Food and Drug Administration. The biologics license application is backed by analytical, pharmacokinetic, and immunogenicity studies, among other data, aimed at establishing biosimilarity between AVT80 and Entyvio, a treatment for adults with moderately to severely active ulcerative colitis and Crohn's disease. AVT80 is designed as a prefilled syringe and autoinjector for subcutaneous administration. Under a partnership, the biotechnology company is developing and manufacturing AVT80, while Teva Pharmaceutical Industries handles its commercialization.