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 factor alpha (TNF-α). The BAT2506 BLA seeks approval for the treatment of all indications currently approved for SIMPONI®, including moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active ulcerative colitis.
Under the terms of the license and commercialization agreement Bio-Thera entered into with Intas Pharmaceuticals Ltd. ("Intas") in February of this year, Bio-Thera will develop and manufacture BAT2506 while Accord BioPharma, the U.S. specialty division of Intas, will commercialize the biosimilar in the United States.
The BAT2506 BLA is the second golimumab BLA referencing J&J's SIMPONI® that has been accepted by the FDA. The BLA for Alvotech's and Teva Pharmaceuticals' AVT05 was accepted in January 2025.
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