On 31 July 2026, judgment was published in relation to procedural matters in proceedings commenced earlier this year in the High Court of England and Wales (Patents Court) by each of Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis (Biosimilar Claimants) against Millennium Pharmaceuticals, a Takeda subsidiary. The Biosimilar Claimants are seeking to clear the way for the UK launch of their biosimilar vedolizumab products, referencing Takeda’s Entyvio®.
In each of the proceedings, the Biosimilar Claimant has applied for the revocation of various Millenium patents and/or for non-infringement declarations or Arrow declarations (that a particular product/process was obvious at the relevant priority date). The patents at issue concern dosing regimens in respect of vedolizumab (EP (UK) 3329965, 3311834 and pending patent applications EP4378484 and EP4438625)) and formulations for vedolizumab (EP (UK) 2704798 and 4403579).
The four proceedings are being heard together and the Biosimilar Claimants have agreed to use their “best endeavours” to align the grounds of invalidity they are relying on by 10 September 2026. A trial is currently scheduled for April 2027.
The July 2026 judgment primarily concerned a dispute between Advanz and Millenium/Takeda in relation to the confidentiality regime applying to information about Advanz’s IV and SC vedolizumab formulations. The parties had agreed that only UK lawyers and two in-house personnel should have access to Advanz’s confidential information and that the in-house individuals should be prohibited from being involved in claim drafting prior to the grant of a patent. Advanz argued that the restriction on claim drafting should also extend to claim amendments or auxiliary requests in foreign proceedings or the European Patent Office for granted patents. In his July 2026 judgment, Mr Justice Mellor concluded that the extended prohibition sought by Advanz should be imposed.
Advanz is the UK, EU and Swiss commercialisation partner for Alvotech’s intravenous vedolizumab biosimilar, AVT16, under a 2023 licence agreement. In June 2026, Alvotech announced that its BLA for AVT16 was the first to be accepted for review by the FDA. Alvotech also has a subcutaneous vedolizumab biosimilar under development, AVT80.
Fresenius Kabi is commercialising Polpharma Biologics’ PB016 (vedolizumab) in the UK, under a global licensing agreement (excluding MENA region) entered in August 2025. On the same date on which the July 2026 judgment was published, Polpharma/Fresenius announced that the Marketing Authorisation Application for PB016 had been accepted for review by the European Medicines Agency (with the corresponding BLA accepted by the FDA).
Accord Healthcare’s parent company, Intas, received approval to conduct a Phase 1 bioequivalence study for its vedolizumab biosimilar, INTP53, in February 2025. Samsung Bioepis’ vedolizumab biosimilar will be commercialised (except in certain Asian countries) by Sandoz under a global licence, development and commercialisation agreement announced in March 2026.