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…
On September 8, Biocon Limited (“Biocon”) announced that, in partnership with Bahiafarma, a Brazilian public pharmaceutical laboratory, and Bionovis, a Brazilian biotechnology company, it had secured a ten-year contract to supply Biocon’s pertuzumab biosimilar, BMAB 1500/PERT-IJS, in Brazil. Pertuzumab is an anti-HER2 monoclonal antibody used to treat HER2-positive breast cancer….
On August 31, 2026, Eli Lilly and Merida Biosciences (“Merida’) announced that they have entered into a definitive agreement for Lilly to acquire Merida. Under the terms of the agreement, Eli Lilly will pay up to $2.875 billion in cash, inclusive of an upfront payment and contingent milestone payments, with…
On August 27, 2026, AbbVie announced that it submitted an application to the European Medicines Agency (“EMA”) seeking approval for SKYRIZI® (risankizumab) for subcutaneous (“SC”) induction for the treatment of adult patients with moderately to severely active Crohn’s disease. This EMA submission follows AbbVie’s FDA submission for the same SKYRIZI®…
On September 1, 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 Alvotech HF (“Alvotech”), alleging that Alvotech’s proposed vedolizumab biosimilar, AVT16, will infringe six patents related to Takeda’s ENTYVIO® (vedolizumab)….
On August 21, 2026, Alvotech announced a licensing and commercialization agreement with Lotus Pharmaceutical (“Lotus”) for AVT34, a proposed biosimilar to IMFINZI® (durvalumab), and AVT87, a proposed biosimilar to HEMLIBRA® (emicizumab). In the United States, Alvotech and Lotus will have semi-exclusive commercialization rights, with Lotus commercializing through its subsidiary Alvogen….
On August 19, 2026, Ultragenyx Pharmaceutical announced that the FDA granted accelerated approval to its GENGLYCOS™ (pariglasgene brecaparvovec-opnr) for patients eight years and older with glycogen storage disease type Ia (GSDIa). The therapy is approved to reduce daily cornstarch intake as an adjunct to nutritional management. It is the first…