FDA to review biosimilar of Entyvio

The FDA has accepted for review Alvotech’s biologics license application (BLA) for AVT16, a proposed interchangeable biosimilar to Takeda’s Entyvio (vedolizumab). Entyvio is approved to treat moderate-to-severe ulcerative colitis and Crohn’s disease.

Assuming a standard review with no extension, Alvotech officials said they expect an FDA decision in the first quarter of 2027.But a biosimilar of Entyvio is not expected to be available soon. Takeda’s patent for Entyvio does not expire until May 2032.

Alvotech’s BLA submission is supported by a data package that includes analytical, pharmacokinetic, and immunogenicity data to support the biosimilarity between AVT16 and the reference product. AVT16 is a biosimilar that would be used for intravenous administration. If approved, it will be marketed by Teva.

In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80, a proposed biosimilar to Entyvio for subcutaneous administration. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 with Entyvio in healthy adult participants and met all its primary endpoints.

In a news release, Alvotech said regulators agreed that the AVT80-GL-P01 clinical study is considered pivotal to support the demonstration of clinical similarity for both AVT16 and AVT80. The study, which assessed the pharmacokinetics, safety, tolerability and immunogenicity of AVT80 compared with Entyvio in healthy adult participants, met all its primary endpoints.

Other Entyvio biosimilars in development include:

• INTP53: The Central Drug Standard Control Organization in India granted Intas Pharmaceuticals permission to initiate a bioequivalence study.
• PB016: Polpharma Biologics is leading development and manufacturing of PB016, and Fresenius Kabi holds commercialization rights worldwide.
• SB36: In March 2026, Samsung Bioepis and Sandoz agreed to development and commercialization agreement for up to five biosimilar candidates, including SB36.