On 8 June 2026, Alvotech announced that its Biologics License Application (BLA) for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), has been accepted for review by the FDA. AVT16 is presented in a lyophilised vial for intravenous administration. This is the first reported FDA application for a vedolizumab biosimilar.
According to Alvotech’s announcement, under a partnership with Teva, Alvotech is responsible for the development and manufacturing of AVT16, while Teva is responsible for its commercialisation. Alvotech and Teva first entered into a strategic partnership in relation to biosimilar candidates in August 2020, which was expanded in 2023.
Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), having announced positive results from a PK study for the product in February 2026.
Other vedolizumab biosimilars are in development, including Intas’ INTP53 (approval to conduct Phase I bioequivalence study received in February 2025) and Polpharma Biologics’ PB016 (global licensing agreement with Fresenius Kabi (excluding MENA region) entered in August 2025, licensing agreement with MS Pharma for MENA region signed in September 2025). In January 2026, Samsung Bioepis announced that it had a vedolizumab biosimilar under early-stage development and, in March 2026, Sandoz announced it entered into a global licence, development and commercialisation agreement (excluding certain Asian countries) with Samsung Bioepis for up to five biosimilars, including vedolizumab.