Alvotech’s BLA for Vedolizumab Biosimilar First to be Accepted by FDA

On June 8, Alvotech announced that the U.S. Food and Drug Administration (“FDA”) has accepted Alvotech’s Biologics License Application (“BLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s ENTYVIO (vedolizumab), for review.  ENTYVIO is a humanized monoclonal antibody approved for the treatment of adults with moderately to several active ulcerative colitis and Crohn’s disease.  AVT16 is being developed as a lyophilized vial for intravenous formulation. In the European Union, the European Medicines Agency has validated a Marketing Authorization Application covering the lyophilized vial presentation in addition to a pre-filled syringe and auto-injector for subcutaneous use (AVT80), although neither AVT16 nor AVT80 have yet received regulatory approval in any market.

AVT16 has been submitted as a proposed interchangeable biosimilar. If approved, AVT16 could be substituted for ENTYVIO at the pharmacy without the intervention of a prescriber, subject to applicable state laws.  According to the press release, Alvotech is developing AVT16 in partnership with Teva Pharmaceutical Industries; while Alvotech is responsible for development and manufacturing of AVT16, Teva is responsible for commercialization.

AVT16 is the first vedolizumab biosimilar to reach the FDA review stage. Alvotech has indicated that it expects an FDA decision on the application in the first quarter of 2027.

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