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…
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two ranibizumab biosimilars, VISLYFA and REXATILUX, recommending granting of a marketing authorization. Ranibizumab is a VEGF-A inhibitor, and can be used to treat macular degeneration via an intravitreal injection; the reference product, LUCENTIS, was…
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 May 10, 2026, Shanghai Henlius Biotech announced that the FDA has approved its IND for a proposed biosimilar, HLX05-N, to Eli Lilly’s ERBITUX (cetuximab) product for the treatment of metastatic colorectal cancer (mCRC). ERBITUX is approved in the United States for the treatment of KRAS wild-type, epidermal growth factor receptor…
On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS™ (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) as an interchangeable biosimilar to SIMPONI ARIA® (golimumab). IMMGOLIS and IMMGOLIS INTRI are the first biosimilars approved for SIMPONI and SIMPONI ARIA….
On April 21, 2026, Biocon announced that Health Canada granted a Notice of Compliance (NOC) for BOSAYATM (denosumab) and VEVZUOTM (denosumab), biosimilars of Amgen’s Prolia® (denosumab) and Xgeva® (denosumab). Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). In Canada,…
As previously reported, litigation between Johnson & Johnson and Janssen (“J&J”) and Samsung Bioepis (“Samsung”) involving Samsung’s Stelara biosimilar, PYZCHIVA (ustekinumab-ttwe) (previously known as SB17), was resolved via a settlement agreement in 2023. Under the terms of the agreement, Samsung received a limited patent license, prohibiting Samsung from sublicensing with…
On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s LANTUS (insulin glargine). LANGLARA is approved for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with…
On April 14, 2026, the United States Food and Drug Administration (“FDA”) issued a draft guidance for sponsors seeking approval of human gene-editing therapy products involving gene-editing technologies. The guidance provides recommendations for assessing the safety of genome-editing therapies to bring effective treatments to patients. The guidance includes considerations for…
On April 22, 2026 Amneal Pharmaceuticals, Inc. announced that it entered into an agreement to acquire Kashiv BioSciences, LLC. Under the terms of the agreement, Amneal will pay $375 million in cash and $375 million in equity at closing, along with up to $350 million in additional milestone and other…