Bio-Thera Solutions has matched Alvotech with the European Medicines Agency accepting for review the Chinese manufacturer’s proposed biosimilar to Johnson & Johnson’s Simponi (golimumab) once-monthly subcutaneous injectable, marking another show of strength for Chinese interest in global biosimilars.
Bio-Thera And Stada Nudge Closer To Limited Golimumab Biosimilar Pool
EMA Will Review Firms’ BAT2506 Candidate, Referencing Simponi SC Injectable
Bio-Thera Solutions has taken the next step towards launching competition to Johnson & Johnon’s Simponi blockbuster, filing its Stada-partnered BAT2506 golimumab candidate with Europe’s regulatory body following successful Phase III comparison data.
