Posted by Michael Wonder on 08 Feb 2025
Bio-Thera Solutions announces regulatory filing acceptance for BAT2506, a proposed biosimilar to Simponi, in the European Union
7 February 2025 - The BAT2506 marketing authorisation application is based on a robust analytical, non-clinical and clinical data package comparing BAT2506 to the reference product Simponi.
Bio-Thera Solutions today announced that the EMA has accepted the marketing authorisation application for BAT2506, a proposed biosimilar to Simponi (golimumab), seeking a commercial license in the European Union.
