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
/ aBLA ,
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 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more