Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2506, a Proposed Biosimilar to Simponi®, in the European Union

The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2506 as a biosimilar to reference product Simponi® The BAT2506 MAA is based on a robust analytical, non-clinical and clinical data package comparing BAT2506 to the reference product...