On September 22, 2026, Biocon Biologics Limited (“Biocon”) announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending marketing authorization for PEBRILZO® (pertuzumab), its biosimilar to Genentech’s PERJETA®. According to Biocon, PEBRILZO® is the first monoclonal antibody biosimilar to receive…
On September 30, 2026, the U.S. District Court for the District of Delaware issued an order granting Janssen Biotech, Inc. and Janssen Sciences Ireland UC’s (collectively, “Janssen”) motion for a preliminary injunction in Janssen Biotech, Inc. v. Accord BioPharma, Inc., No. 1:26-cv-00222 (D. Del.). The order enjoins defendants Accord BioPharma,…
STADA and Sino Biopharmaceutical Limited (“SBP Group”), through its subsidiary Chia Tai Tianqing Pharmaceutical Group (“CTTQ”), have entered into a partnership to manufacture, market, and sell biosimilars. CTTQ will develop, manufacture, and supply biosimilar candidates, while STADA will hold the marketing authorizations and have exclusive sales and marketing rights in…
On September 9, 2026, the U.S. Patent and Trademark Office issued a Notice of Decisions on Institution granting institution in four inter partes review proceedings challenging Janssen Biotech, Inc.’s golimumab method-of-treatment patents: IPR2026-00256, IPR2026-00257, IPR2026-00258, and IPR2026-00259. The notice states, “after review of the merits, the petitioner has shown a…
On September 17, 2026, Dualitas Therapeutics, Inc. (“Dualitas”) announced a research collaboration and license agreement with Roche to advance novel bispecific antibodies (“BsAbs”) for immunology and inflammation diseases, using Dualitas’ DualScreen Bispecific Discovery Engine. Under the collaboration, Dualitas will functionally screen over 300,000 novel bispecific combinations to discover and develop…
On September 15, 2026, GSK plc (“GSK”) announced that it agreed to acquire a trispecific T cell-engager (“TCE”) from Chimagen Biosciences (“Chimagen”), a privately held biotechnology company. GSK plans to develop and commercialize the asset for multiple myeloma, with phase I trials expected to begin in 2027. According to the…
Ultragenyx Pharmaceutical, Inc. has announced FDA approval for FAYUVI (rebisufligene etisparvovec-hopf), a first-ever treatment to stop or slow the progression of mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A. MPS IIIA is an ultra-rare inherited lysosomal storage disorder caused by deficiency of the sulfamidase (SGSH) enzyme,…
As we previously reported, portions of CareFirst’s antitrust claims concerning STELARA® (ustekinumab) survived summary judgment in December 2025. On January 14, 2026, the U.S. District Court for the Eastern District of Virginia reconsidered that decision and granted summary judgment to Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) on…
On September 8, 2026, Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., (collectively, “BMS”) and Ono Pharmaceutical Co., Ltd. (“Ono”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Amgen Inc. (“Amgen”), alleging that Amgen’s proposed nivolumab biosimilar, ABP 206, will infringe seven…
On September 3, 2026, InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, announced a strategic partnership and exclusive license with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck’s KEYTRUDA® (pembrolizumab), in the United States. Pembrolizumab is a humanized monoclonal antibody that…