STADA and Bio-Thera Receive EU Approval for Gotenfia Biosimilar to Simponi
The European Commission has approved Gotenfia (golimumab), a biosimilar to Simponi developed by Bio-Thera and marketed by STADA, for chronic inflammatory autoimmune diseases across the EU and EEA.
Global healthcare company STADA and biopharmaceutical company Bio-Thera Solutions have received marketing authorization from the European Commission for Gotenfia (golimumab), a biosimilar referencing Simponi. The authorization covers several chronic inflammatory autoimmune diseases and applies across the European Union and European Economic Area.
The authorization follows a recommendation in December 2025 from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA). Launch preparations are underway to bring this therapeutic option to patients across Europe in the coming weeks and months.
Being the second biosimilar to Simponi approved in the EU, Gotenfia—developed by Bio-Thera under the product code BAT2506—will significantly spur market competition, which is expected to increase treatment access for many more patients at lower unit costs. The approval marks STADA's 11th biosimilar authorization in total.
The Global Specialty Head stated that the company looks forward to increasing competition on this well-established anti-TNF therapy, noting years of experience supplying adalimumab and ustekinumab biosimilars and the considerable impact that access to biological treatments for chronic autoimmune and inflammatory conditions can have on patients' quality of life.
The CEO of Bio-Thera Solutions said bringing this convenient, once-monthly treatment option to rheumatologists, gastroenterologists and the patients they serve marks a major milestone in Bio-Thera's commitment to being one of the premier biosimilar developers and manufacturers in the world. Building on prior approvals and launches in the US and EU, this European authorization further establishes Bio-Thera as a major global biosimilar developer and manufacturer.
The marketing authorization and positive CHMP opinion on Gotenfia were 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 authorization 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 Liechtenstein.
Bio-Thera and STADA entered into a license and commercialization 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 commercialize the product in the European Union, the UK, Switzerland and selected other countries. In 2025, the two partners announced an extension of their alliance to cover the immunosuppressant monoclonal antibody tocilizumab for which launch preparations are also underway.
Gotenfia is a biosimilar to Simponi, a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. Gotenfia has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.