On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi), an intravenous biosimilar to Genentech’s ACTEMRA® (tocilizumab). The approval expands TOFIDENCE’s indications to include: (1) adults and pediatric patients (2 years of age and older)…
On June 4, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced the launch of its aflibercept biosimilar, AHZANTIVE®, in Europe. According to Teva’s press release, the launch of AHZANTIVE® pre-filled syringes across European markets commenced in May 2026. The launch follows Teva’s semi-exclusive commercialization agreement with Klinge Biopharma GmbH and Formycon…
On June 8, Incyte announced that it has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics. The transaction would add VGA039, an investigational monoclonal antibody in Phase 3 development for von Willebrand disease, to Incyte’s hematology portfolio. Under the agreement, Incyte will…
On June 5, Lupin announced that the U.S. Food and Drug Administration (“FDA”) approved RANLUSPEC, a ranibizumab biosimilar to Genentech’s LUCENTIS®. RANLUSPEC, which received European Marketing Authorization earlier this year, is indicated for the treatment of neovascular (wet) age-related macular degeneration and other retinal vascular disorders. It is the only…
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…