NASDAQ — Healthcare: Manufacturing, Drug Manufacturers - Specialty & Generic: Biological Products (No Disgnostic Substances)
www.alvotech.comThe FDA has set Q4 2025 as the goal date for approval of Biologics License Applications for three new biosimilar candidates developed by Alvotech in partnership with Teva.
fda decisionAlvotech Swiss AG is conducting a Phase 1 clinical trial (NCT06732804) comparing AVT80, a proposed biosimilar to Entyvio (vedolizumab), with the reference product. The study focuses on comparative pharmacokinetics, safety, immunogenicity, and tolerability in healthy subjects. The trial is expected to complete on October 1, 2025. Entyvio is a monoclonal antibody used for inflammatory bowel diseases, and AVT80 aims to expand biosimilar options in this therapeutic area.
trial completionAlvotech Swiss AG is conducting a Phase 3 clinical trial comparing AVT16, a proposed biosimilar, to Entyvio (vedolizumab) in terms of efficacy, safety, and immunogenicity. The trial, which began in September 2024 and is currently recruiting, is expected to complete on August 31, 2026. Entyvio is a monoclonal antibody used to treat ulcerative colitis and Crohn's disease. AVT16 aims to offer a lower-cost alternative in the inflammatory bowel disease market.
trial completion