On August 26, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Polpharma Biologics S.A. (“Polpharma”), alleging that Polpharma’s vedolizumab biosimilar, PB016, will infringe six patents related to Takeda’s ENTYVIO (vedolizumab). This is the first BPCIA case involving a vedolizumab biosimilar.
Takeda alleges infringement of U.S. Patent Nos. 9,663,579; 10,004,808; 12,053,526; 12,171,832; 12,544,445; and 12,622,969, all generally related to methods of treatment, or methods of “achieving clinical response” or “inducing clinical remission” using a certain dosing regimen with vedolizumab.
Takeda alleges that Polpharma announced a partnership with Fresenius Kabi USA, LLC in 2025 to commercialize PB016 and has submitted an abbreviated Biologics License Application (“aBLA”) to market the product. Takeda also alleges that, on June 18, 2026, Polpharma provided Notice of Commercial Marketing, stating that it intends to commence commercial marketing of PB016 no earlier than 180 days from that date. According to Takeda, “counsel for Polpharma informed counsel for Takeda that approval of Polpharma’s aBLA is expected in May 2027.”
Takeda seeks a declaratory judgment that Polpharma has infringed or will infringe the asserted patents, an injunction to prevent Polpharma from manufacturing, using, offering to sell, selling, distributing, and importing any current or future version of PB016, damages, attorneys’ fees, and costs.
Stay tuned to Big Molecule Watch for further updates on this new BPCIA litigation.