On 31 July 2026, Polpharma Biologics and Fresenius Kabi announced that Polpharma’s Biologics License Application (BLA) and Marketing Authorisation Application (MAA) for PB016 (vedolizumab), biosimilar to Takeda’s Entyvio®, have been accepted for review by the FDA and European Medicines Agency (EMA), respectively. In both regions, PB016 is delivered in a lyophilised vial for intravenous administration and is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.
The biosimilar was developed by Polpharma Biologics, and Fresenius Kabi holds the exclusive commercialisation rights (excluding the MENA region) under a global licensing agreement announced in August 2025. Polpharma entered into a licensing agreement with MS Pharma for commercialisation of PB016 (and other biosimilars) in the MENA region in September 2025.
In February 2024, Polpharma announced that PB016 demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®. A phase 3 trial comparing PB016 to Entyvio® in patients with ulcerative colitis was also undertaken.
The first FDA acceptance of a BLA for a vedolizumab biosimilar was in June 2026, for Alvotech’s AVT16 (lyophilised vial for IV administration). AVT16 will be commercialised by Teva under a strategic partnership entered in August 2020 and expanded in 2023. Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), with positive results from a PK study for the product announced in February 2026.
Other vedolizumab biosimilars are 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).