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 Intas will handle commercialization of the product.
Just a few days prior, on February 7, 2025, Bio-Thera announced that the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for BAT2506. Bio-Thera had entered into an exclusive licensing agreement with STADA Arzneimittel AG to commercialize BAT2506 in the European Union (UK), the United Kingdom (UK), Switzerland, and selected other countries. Under the terms of the agreement, Bio-Thera will maintain responsibility for the development, manufacturing, and supply of BAT2506, while STADA will handle commercialization of the product.
Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. According to Bio-Thera, binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. Janssen Biotech’s SIMPONI® (golimumab) is approved in the United States and Europe for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.