On 1 September 2026, Takeda commenced BPCIA proceedings against Alvotech in the US District Court for the District of New Jersey in relation to Alvotech’s AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab). The litigation against Alvotech follows closely behind Takeda’s BPCIA proceedings against Polpharma filed in the same court on 26 August 2026 regarding Polpharma’s PB016 (vedolizumab).
In its complaint against Alvotech, Takeda alleges infringement of the same six US patents asserted against Polpharma 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 proceedings arise from the FDA’s acceptance of Alvotech’s abbreviated Biologics License Application (aBLA) for AVT16, announced on 8 June 2026. Takeda’s complaint discloses that Alvotech notified Takeda on 15 June 2026 of the FDA acceptance of the aBLA for AVT16 (injection for intravenous use in 300 mg single use vials) as an interchangeable biosimilar to Entyvio®.
Takeda is seeking remedies including preliminary and permanent injunctions to restrain the importation and sale of AVT16 in the US, and damages.
Under a strategic partnership entered in August 2020 and expanded in 2023, Alvotech granted to Teva the exclusive rights to commercialise AVT16 in the US. According to the complaint filed with the US Court, in exchange for the licence, Teva agreed to pay Alvotech US$56 million, plus certain milestone payments. Under a Product Supply Agreement, Teva also agreed to pay Alvotech’s cost of goods sold for each unit of AVT16 plus an additional percentage.
Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), with positive results from a PK study for the product announced in February 2026. AVT80 is not named in the BCPIA litigation.
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 of vedolizumab (EP (UK) 2704798 and 4403579).