On August 20, 2026, the FDA published guidance intended to provide answers to frequently asked questions about the development of cellular and gene therapy (“CGT”) products to help facilitate the development of safe, effective, and high-quality CGT products. The FDA’s guidance is in response to the Prescription Drug Use Fee…
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)….
Formycon AG (“Formycon”) announced its partnership with OneSource Specialty Pharma Limited (“One Source”) on July 14, 2026. OneSource, located in Bangalore, India, will complement Formycon’s biosimilar development experience with its biologics manufacturing capabilities. OneSource has an integrated biologics platform that ranges from cell line development to commercial fill-finish and five…
On June 12, 2026, Xbrane Biopharma AB (“Xbrane”) and JOINN Biologics US Inc. (“JOINN”) announced a strategic partnership to develop Xdarzane, Xbrane’s biosimilar candidate to DARZALEX (daratumumab), which is approved for the treatment of multiple myeloma. Big Molecule Watch has previously covered daratumumab biosimilar development, including Dr. Reddy’s 2025 license…