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…
On August 19, 2026, the U.S. Food and Drug Administration approved Regeneron’s PASATRU™ (garetosmab-grts) for the treatment of adults with fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder characterized by progressive heterotopic ossification (HO), the formation of bone in muscles, tendons, ligaments, and other connective tissues. According to Regeneron, PASATRU…
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)….
On August 18, 2026, Biocon Ltd. (“Biocon”) announced that its U.S. subsidiary has received supplemental U.S. FDA approval for YESINTEK® (ustekinumab-kfce) in a single-dose prefilled autoinjector, 45 mg/0.5 mL and 90 mg/mL. YESINTEK® was originally approved by the FDA on November 29, 2024, in 45 mg/0.5 mL or 90 mg/mL…