On 26 August 2026, Takeda commenced BPCIA proceedings against Polpharma in the US District Court for the District of New Jersey in relation to Polpharma’s PB016, biosimilar to Takeda’s Entyvio® (vedolizumab). Takeda alleges infringement of six US patents relating to vedolizumab; its administration to treat inflammatory bowel disease, ulcerative colitis, and Crohn’s disease; and its formulation and method of manufacture (US patent numbers 9,663,579; 10,004,808; 12,053,526; 12,171,832; 12,544,445; and 12,622,969).
The US litigation follows UK litigation commenced earlier this year against Takeda by a number of biosimilar manufacturers seeking to clear the way for their vedolizumab products, as discussed further below.
The BPCIA proceedings arise from Polpharma’s submission of an abbreviated Biologics License Application (aBLA) to the FDA, seeking approval to market its vedolizumab biosimilar for intravenous (IV) infusion. While the date of the aBLA submission is confidential, Takeda’s complaint discloses that Polpharma provided a Notice of Commercial Marketing to Takeda on 18 June 2026, confirming that Polpharma and its commercial marketing partner, Fresenius Kabi, will commence commercial marketing of PB016 (IV) no earlier than 15 December 2026 (being 180 days from the date of the notice). However, according to the complaint, Polpharma’s counsel informed counsel for Takeda that approval of the aBLA is expected in May 2027. Takeda is seeking remedies including preliminary and permanent injunctions to restrain the importation and sale of PB016 in the US, and damages.
PB016 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.
Polpharma announced on 31 July 2026 that its aBLA for PB016 was accepted for review by the FDA in a lyophilised vial for IV administration, indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. Acceptance of the marketing authorisation application for PB016 by the European Medicines Agency was announced on the same date.
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).
Fresenius Kabi, Advanz Pharma (Alvotech’s UK/EU commercialisation partner), Accord Healthcare (an Intas subsidiary) and Samsung Bioepis (together, Biosimilar Claimants) each commenced proceedings earlier this year in the High Court of England and Wales against Millennium Pharmaceuticals, a Takeda subsidiary. The Biosimilar Claimants are seeking to clear the way for the UK launch of their biosimilar vedolizumab products and have applied for the revocation of various Millenium patents and/or for non-infringement declarations or Arrow declarations. 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).