STADA Arzneimittel AG and Bio-Thera Solutions have received marketing authorisation from the European Commission (EU) for Gotenfia (golimumab), a biosimilar referencing Simponi.

The approval is valid across all 27 European Union member states as well as Norway, Iceland and Liechtenstein within the European Economic Area (EEA). The authorisation follows a positive opinion issued in December 2025 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Gotenfia, developed by Bio-Thera under the code BAT2506, is the second biosimilar to Simponi approved in the EU. It is indicated for the treatment of several chronic inflammatory autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

The marketing authorisation covers Gotenfia 50mg/0.5mL and 100mg/mL solution for injection in pre-filled syringes equipped with passive needle safety guards.

The approval was supported by a comprehensive package of analytical, non-clinical and clinical data demonstrating biosimilarity to the reference product. The totality of evidence confirmed comparable efficacy, safety and quality profiles.

Under a licensing and commercialisation agreement signed in May 2024, Bio-Thera is responsible for the development, manufacturing and supply of BAT2506, while STADA holds exclusive commercialisation rights in the European Union, the United Kingdom, Switzerland and selected additional territories.

In 2025, the companies expanded their partnership to include the immunosuppressant monoclonal antibody tocilizumab, with launch preparations currently underway.

Simponi is a human IgG1 monoclonal antibody that targets Tumour Necrosis Factor alpha (TNF-α), a pro-inflammatory cytokine involved in autoimmune disease pathways. Binding of golimumab to TNF-α leads to reductions in inflammatory biomarkers such as 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).

Gotenfia has been approved in Europe for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

Johnson & Johnson holds the registered trademark for Simponi, while Gotenfia is a registered trademark of STADA.

Headquartered in Bad Vilbel, Germany, STADA operates under a three-pillar strategy focused on consumer healthcare products, generics and specialty pharmaceuticals. The company markets its products in more than 100 countries worldwide. In the financial year 2024, STADA reported group sales of Euro 4,059 million and adjusted constant-currency EBITDA of EURo 886 million.

Bio-Thera Solutions, based in Guangzhou, China, is a global biopharmaceutical company engaged in the research and development of innovative therapies for cancer, autoimmune disorders, cardiovascular diseases, ophthalmology and other serious medical conditions, alongside biosimilars targeting established biologics.