On June 8, Alvotech announced that the U.S. Food and Drug Administration (“FDA”) has accepted Alvotech’s Biologics License Application (“BLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s ENTYVIO (vedolizumab), for review. ENTYVIO is a humanized monoclonal antibody approved for the treatment of adults with moderately to several active ulcerative…
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 29, 2026, Boan Biotech announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for BA6101 (denosumab; injection 60 mg) and BA1102 (denosumab; injection 120 mg), referencing Amgen’s PROLIA® (denosumab) and XGEVA® (denosumab), respectively. According to Boan Biotech, the submission is…
On May 22, 2026, Polpharma Biologics announced that it had entered into an exclusive licensing agreement with Tuteur to commercialize a biosimilar targeting autoimmune diseases across Latin America, excluding Brazil. The parties did not disclose which specific biosimilar is covered by the license. Under the agreement, Polpharma Biologics will retain…
On May 29, 2026, Samsung Bioepis Co., Ltd. announced the European launch of OPUVIZ, a biosimilar referencing EYLEA (aflibercept). OPUVIZ will be available as a 40 mg/mL solution for injection. Commenting on the launch, Antonio Rito, Vice President and Head of Europe at Samsung Bioepis, stated: “We are pleased to…
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….