On August 3, 2026, Biocon Limited announced the commercial launch of its biosimilar YESAFILI (aflibercept-jbvf) in the United States. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor that is used to treat various ophthalmic conditions. YESAFILI references Regeneron’s EYLEA (aflibercept) 2 mg product. The FDA approved YESAFILI as an…
On July 9, 2026, Accord BioPharma announced that the FDA approved ENNUMO (pegfilgrastim-pccg). ENNUMO references Amgen’s NEULASTA (pegfilgrastim). The FDA approved ENNUMO on May 7, 2026, for the same indications as NEULASTA: for adult and pediatric patients, to decrease the incidence of infections, as manifested by febrile neutropenia, in patients…
On June 2, 2026, Chime Biologics and Daewoong Pharmaceutical announced a strategic partnership agreement for the development and manufacturing of a dupilumab biosimilar candidate referencing Sanofi and Regeneron’s DUPIXENT. Chime Biologics is a global CDMO headquartered in China and with major development hubs in Basel, Shanghai, and Wuhan. Daewoong is…
On May 26, 2026, Amneal Pharmaceuticals, Inc. and Kashiv Biosciences petitioned for inter partes review (IPR2026-00260) of all claims of U.S. Patent No. 12,030,959 (“the ’959 patent”), assigned to Novartis AG and Genentech, Inc. The ’959 patent is generally directed to methods for treating pediatric patients having food allergies by…
On May 26, 2026, Eli Lilly announced that it had entered into agreements to acquire LimmaTech Biologics AG, Curevo Inc., and Vaccine Company, Inc. as part of its expanded research and development efforts in infectious disease. LimmaTech is a Swiss clinical-stage biotech company currently developing vaccines against antibiotic-resistant bacteria, including…
On April 7, 2026, Biocon Limited announced that it had launched BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) in the United States. Both products are RANK ligand inhibitors used to treat conditions such as osteoporosis and cancer-related skeletal complications. BOSAYA™ and AUKELSO™ have been designated as interchangeable with their corresponding reference products,…
On March 18, 2026, Sandoz announced a new license, development, and commercialization partnership agreement with Samsung Bioepis Co., Ltd. Under this agreement, the companies will collaborate on the development and commercialization of up to five biosimilar assets, with the potential for further collaboration. Sandoz will have exclusive global commercialization rights,…
As we head into what is anticipated to be a strong year for biopharma dealmaking, we look back at some of the biggest deals in 2025 that focus on biologics and biosimilars. Antibody Therapy Deals Novartis acquires Avidity Biosciences On October 26, 2025, Novartis AG and Avidity Biosciences, Inc. announced…
Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord. On December 1, 2025: Sandoz launched its denosumab biosimilars, WYOST (120 mg) and JUBBONTI (60 mg) in Europe. WYOST is approved for the treatment of…
Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled syringe presentation, referencing Amgen’s NEULASTA. ARMLUPEG is indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies who are receiving…