On 5 August 2025, Polpharma Biologics and Fresenius Kabi announced that they have entered into a global licensing agreement (excluding Middle East & North Africa) for the commercialisation of PB016, biosimilar to Takeda’s Entyvio® (vedolizumab). PB016 was developed by Polpharma, which will remain responsible for manufacture. Fresenius Kabi will be responsible for commercialisation.
In February 2024, Polpharma Biologics announced that PB016 demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®. Phase 3 trials comparing PB016 to Entyvio® are underway, with estimated completion in September 2025.
There are a number of other vedolizumab biosimilars in development. In February 2025, Intas Pharmaceuticals received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)). In September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis. Alvotech’s AVT16 is subject to a 2023 licence agreement with Advanz, under which Advanz will commercialise the biosimilar in Europe, the UK and Switzerland.