On 31 August 2026, Alvotech announced that the FDA has accepted for review its Biologics License Application (BLA) for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), in prefilled syringe and autoinjector forms for subcutaneous administration. Alvotech announced positive results from a PK study for AVT80 in February 2026.
Under a partnership with Teva, Alvotech is responsible for the development and manufacture of AVT80, while Teva is responsible for its US commercialisation. Alvotech and Teva first entered into a strategic partnership in relation to biosimilar candidates in August 2020, which was expanded in 2023.
Alvotech’s BLA for its intravenous (IV) biosimilar vedolizumab, AVT16, was the first reported vedolizumab biosimilar BLA to be accepted for review by the FDA in May 2026 (announced in June 2026). Alvotech’s commercialisation partners for AVT16 are Teva in the US and Advanz in the UK, EU and Switzerland.
Polpharma/Fresenius Kabi’s BLA and Marketing Authorisation Application (MAA) for the vedolizumab biosimilar PB016 were accepted for review by the FDA and European Medicines Agency (EMA), respectively, in July 2026. In both regions, PB016 is delivered in a lyophilised vial for IV administration and is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.
Other vedolizumab biosimilars are also under development, including by Intas (Indian approval to conduct Phase I bioequivalence study of INTP53 in February 2025) and Samsung Bioepis (in early-stage development, global licence, development and commercialisation agreement (excluding certain Asian countries) entered with Sandoz in March 2026).
Litigation regarding vedolizumab biosimilars is currently underway in the UK (court applications to revoke Takeda/Millenium patents relating to vedolizumab filed by Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis earlier this year) and the US (BPCIA litigation commenced by Takeda against Polpharma in August 2026).