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...more
7/30/2025
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Biologics ,
Biosimilars ,
Biotechnology ,
Clinical Trials ,
Drug Pricing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
License Agreements ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Teva Pharmaceuticals
On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the U.S. launch of EPYSQLI® (eculizumab-aagh), a biosimilar referencing Alexion Pharmaceuticals’ SOLIRIS®....more