On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of SIMPONI®, in the United States. According to the agreement, Bio-Thera will maintain responsibility for the development, manufacturing, and supply of BAT2506, while…
On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen’s STELARA. STEQEYMA is approved for subcutaneous injection or intravenous infusion in adult and pediatric patients for treatment of various psoriatic conditions, Crohn’s disease, and ulcerative colitis. STEQEYMA is the seventh ustekinumab biosimilar…