Alvotech AVT80 biosimilar enters FDA review

• The FDA accepted Alvotech’s Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio.
• The application covers prefilled syringe and autoinjector formats for subcutaneous administration.
• Alvotech said its Teva partnership will support development and manufacturing, while Teva will handle commercialization.

Alvotech (NASDAQ:ALVO) announced that the U.S. Food and Drug Administration accepted its Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector formats.

The FDA review follows Alvotech’s previous application for AVT16, a proposed interchangeable biosimilar to intravenous Entyvio that was accepted by the agency in May 2026.

The AVT80 application includes analytical, pharmacokinetic, and immunogenicity data, including a randomized, double-blind pivotal pharmacokinetic study in healthy adults that met all primary endpoints when compared with Entyvio.

Alvotech said regulatory guidance supports using the study to demonstrate clinical similarity for both AVT80 and AVT16.

Alvotech develops biosimilar medicines and has partnered with Teva, with Alvotech responsible for development and manufacturing and Teva responsible for commercialization activities.

The European Medicines Agency has validated a Marketing Authorization Application covering both AVT16 and AVT80, while Alvotech said the products remain investigational and biosimilarity and interchangeability have not yet been established or approved in any market.