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.
Foresee Pharmaceuticals receives positive CHMP opinion for CAMCEVI 21 mg
Great Novel Therapeutics' GNTbm-38 approved by US FDA for Phase I trial
Johnson & Johnson reports US FDA approval of TECVAYLI plus DARZALEX FASPRO for RRMM
Airiver Medical's Airiver Pulmonary DCB receives US FDA Breakthrough Device Designation
Sanaregen receives FDA clearance for retinal degeneration clinical trial
Esperion to acquire Corstasis, expanding cardiovascular portfolio
ReviR Therapeutics doses first participant in First-in-Human Phase 1 clinical trial of RTX-117
BD receives FDA clearance for Surgiphor 1000mL irrigation system
United Therapeutics' ralinepag reduces risk of clinical worsening in pivotal PAH study
FDA accepts rusfertide NDA and grants priority review for polycythemia vera