Chinese biopharmaceutical company Bio-Thera Solutions Inc (SHA:688177) said on Friday that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for BAT2506, a proposed biosimilar to Simponi (golimumab).

The reference drug is approved in Europe for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

The MAA submission is supported by analytical, non-clinical and clinical data demonstrating BAT2506's biosimilarity to Simponi. Analytical studies confirmed structural and biological similarity, while Phase 1 and Phase 3 clinical trials evaluated pharmacokinetics, safety and efficacy.

Bio-Thera Solutions has an agreement with STADA Arzneimittel AG to commercialize BAT2506 in the European Union, the UK, Switzerland and selected other markets. Bio-Thera Solutions retains responsibility for development, manufacturing and supply, while STADA holds exclusive regulatory and commercial rights.