On 8 January 2026, Takeda announced that it has entered a global collaboration and licence agreement with Halozyme Therapeutics, Inc, which grants Takeda exclusive rights to Halozyme’s Enhanze® drug delivery technology for use with Takeda’s Entyvio® (vedolizumab).
Under the agreement, Takeda will make an upfront payment and potential future development and commercial milestone payments to Halozyme. Halozyme will also receive royalties on sales of products containing vedolizumab in combination with Enhanze®.
Entyvio® is approved including in the US and EU for adults with ulcerative colitis and moderately to severely active Crohn’s disease in both IV and subcutaneous formulations.
There are a number of vedolizumab biosimilars in development. 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.
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 August 2025 and September 2025 respectively, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab) and a licence agreement with MS Pharma for commercialisation in the MENA region of a number of biosimilars, including PB016.