Specialty, generic and consumer healthcare medicines company STADA and Bio-Thera Solutions (SH:688177), a commercial-stage biopharmaceutical company, announced on Friday that they have received marketing authorisation from the European Commission for their Gotenfia (golimumab) biosimilar referencing Simponi.

Gotenfia's authorisation for several chronic inflammatory autoimmune diseases, which applies across the European Union and European Economic Area (EEA), follows a recommendation in December 2025 from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA).

Gotenfia was developed by Bio-Thera and will be marketed by STADA. As the second biosimilar to Simponi approved in the EU, Gotenfia is expected to spur market competition, expanding treatment access for more patients at lower unit costs.

Approval was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package demonstrating that Gotenfia is biosimilar to its reference product. The marketing authorisation for Gotenfia 50mg/0.5mL and 100mg/mL solution for injection in pre-filled syringes with passive needle safety guards applies across the 27 EU member states, in addition to Norway, Iceland and Lichtenstein.

Bio-Thera and STADA entered into a licence and commercialisation agreement for BAT2506 in May 2024. Under the terms of the agreement, Bio-Thera is responsible for development, manufacture and commercial supply. STADA holds exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.