Alvotech said the U.S. Food and Drug Administration (FDA, U.S. medicines regulator) accepted for review its Biologics License Application (BLA, application for biologic approval) for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab). The candidate is being developed for subcutaneous administration through a prefilled syringe and autoinjector, while partner Teva Pharmaceutical Industries Ltd. would commercialize it and Alvotech would handle development and manufacturing. The filing is supported by analytical, pharmacokinetic and immunogenicity data. A pivotal study reported positive results in February 2026, and the program also includes AVT16, an intravenous candidate whose BLA was accepted in May 2026. Neither product has regulatory approval, and biosimilarity or interchangeability has not been established by authorities. In the European Union, the European Medicines Agency has validated an application covering both candidates.