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European Commission grants approval for Gotenfia, a golimumab biosimilar to Simponi that was developed by Bio-Thera and will be marketed by STADA.
February 13, 2026
By: Charlie Sternberg
Associate Editor
The European Commission has approved STADA and Bio-Thera Solutions’ Gotenfia, a biosimilar to Johnson & Johnson’s Simponi, clearing the way for its rollout across the European Union and European Economic Area. The authorization covers multiple chronic inflammatory autoimmune conditions and follows a positive recommendation issued in December 2025 by the European Medicines Agency’s Committee for Medicinal Products for Human Use. STADA said launch preparations are underway, with product ava...
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