On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny). STARJEMZA references Janssen’s STELARA, and is indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Craig Boyd, commercial lead for the biosimilar, commented that “We…
On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. MYNZEPLI® will be available as a 40 mg/mL solution in a pre-filled syringe and vial and is approved for the same adult indications as…
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing Johnson & Johnson’s (“J&J”) SIMPONI®. Golimumab is a human IgG1 monoclonal antibody that blocks the inflammatory effects of tumor necrosis…
On May 22, 2025, the FDA approved Bio-Thera Solutions and Hikma Pharmaceuticals’ ustekinumab biosimilar, STARJEMZA® (ustekinumab-hmny) injection, referencing Janssen’s STELARA® (ustekinumab) injection. This approval makes Bio-Thera the seventh company to receive FDA approval for an ustekinumab biosimilar, joining Amgen, Alvotech, Samsung, Fresenius, Accord, Biocon, and Celltrion. Ustekinumab is a human…
This Monday, Bio-Thera Solutions and Dr. Reddy’s Laboratories SA announced that they had entered into commercialization and licensing agreements for proposed ustekinumab and golimumab biosimilars in Southeast Asia. Bio-Thera will develop, manufacture, and supply BAT2206 (the proposed ustekinumab biosimilar referencing Janssen’s STELARA) and BAT2506 (the proposed golimumab biosimilar referencing Janssen’s…