Can Gotenfia finally unlock biosimilar competition for Simponi in Europe?
STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed