FDA accepts BLA for Alvotech's AVT80, a subcutaneous Entyvio biosimilar candidate

Alvotech announced on August 31, 2026 that the FDA has accepted for review a Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration.¹

Alvotech is developing and manufacturing AVT80 under a partnership with Teva Pharmaceutical Industries Ltd., with Teva handling commercialization.¹ Joseph McClellan, Alvotech's Chief Operating Officer, said the acceptance marks another step forward for the company's vedolizumab biosimilar program. He noted that combined with the AVT16 application accepted in May, the overall program now spans both intravenous and subcutaneous delivery, including a prefilled syringe and autoinjector.¹

The BLA submission is backed by analytical, pharmacokinetic, and immunogenicity data intended to support biosimilarity to the reference product.¹ AVT80 was submitted as a proposed interchangeable biosimilar, a designation that in the United States would allow pharmacy-level substitution for the reference product without prescriber involvement, subject to applicable law.¹

In February 2026, Alvotech reported positive results from a pivotal pharmacokinetic study. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints.¹ Based on regulatory input, this study is considered pivotal for demonstrating clinical similarity for both AVT16 and AVT80.¹

Outside the U.S., the European Medicines Agency has validated a Marketing Authorization Application that includes both the AVT16 lyophilized vial formulation and the AVT80 prefilled syringe and autoinjector formulations.¹ The company noted that both AVT16 and AVT80 remain investigational, with biosimilarity and interchangeability not yet established by any regulatory authority.¹