Posted by Michael Wonder on 14 Feb 2026
STADA and Bio-Thera receive European marketing authorization for Gotenfia, a biosimilar to Simponi
13 February 2026 - STADA and Bio-Thera Solutions have received a marketing authorisation from the European Commission for their Gotenfia (golimumab) biosimilar referencing Simponi.
The authorisation of Gotenfia for several chronic inflammatory autoimmune diseases, which applies across the European Union and European Economic Area, follows a recommendation in December 2025 from the CHMP within the EMA.
