On September 18, 2026, Sandoz announced a licensing, development, manufacturing, and commercialization agreement with mAbxience for a proposed biosimilar to Genentech’s HEMLIBRA® (emicizumab). HEMLIBRA® is approved for the treatment of hemophilia A.
According to Sandoz, the collaboration would add its
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
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.,
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
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,
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
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
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
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
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
