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....more
On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more
2/18/2025
/ Biosimilars ,
Compliance ,
Department of Health and Human Services (HHS) ,
European Commission ,
Food and Drug Administration (FDA) ,
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Regulatory Requirements
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...more
As we previously reported, in April of last year, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC brought a lawsuit against Pfizer and BioNTech in the District Court for the District of Delaware, alleging that...more