Under a partnership with Teva Pharmaceutical Industries, Alvotech is responsible for developing and manufacturing AVT80, while Teva will handle commercialization.

“FDA’s acceptance for review of our BLA for AVT80 is another important milestone for our vedolizumab biosimilar program,” says Joseph McClellan, Chief Operating Officer of Alvotech. “Together with our BLA for AVT16, which was accepted for review in May, the program encompasses both intravenous and subcutaneous presentations, including a prefilled syringe and autoinjector.”

Entyvio is a biologic medicine approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

The BLA submission is backed by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT80 and the reference product.

AVT80 has been submitted as a proposed interchangeable biosimilar. In the US, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws. If approved, AVT80 would expand the range of biosimilar options available to patients and healthcare providers in the US.

In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study of AVT80. 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. Based on regulatory advice, the study is considered pivotal in supporting the demonstration of clinical similarity for both AVT16 and AVT80.