Global healthcare player STADA and biopharmaceutical company Bio-Thera Solutions have won European Commission approval for Gotenfia (golimumab), a biosimilar referencing Simponi, paving the way for wider patient access across Europe.
The European Commission’s green light covers multiple chronic inflammatory autoimmune diseases and follows a December 2025 recommendation from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).
Launch preparations are now underway, with patients expected to benefit in the coming weeks and months. As the EU’s second approved Simponi biosimilar, Gotenfia —developed by Bio-Thera under the code BAT2506—is expected to intensify market competition and lower treatment costs.
"Having received the European marketing authorization, our 11th for a biosimilar in total, we look forward to increasing competition on this well-established anti-TNF therapy," said Bryan Kim, STADA’s Global Specialty Head.
"We know from our years of experience supplying adalimumab and ustekinumab biosimilars the considerable impact that access to biological treatments for chronic autoimmune and inflammatory conditions can have on patients' quality of life."
"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," added Shengfeng Li, CEO of Bio-Thera Solutions.
"Building on our 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 approval is backed by extensive analytical, non-clinical, and clinical data demonstrating that Gotenfia matches its reference product. It applies to 50mg/0.5mL and 100mg/mL pre-filled syringes with passive needle safety guards, covering all 27 EU member states plus Norway, Iceland, and Liechtenstein.
Under a May 2024 license and commercialization deal, Bio-Thera handles development, manufacturing, and supply, while STADA holds exclusive commercialization rights in the EU, UK, Switzerland, and selected other countries. In 2025, the partners extended their collaboration to include the immunosuppressant monoclonal antibody tocilizumab, with launch preparations also in progress.
Gotenfia is a biosimilar to Simponi, a human IgG1 monoclonal antibody targeting tumor necrosis factor alpha (TNF-α). By binding TNF-α, golimumab reduces key inflammatory markers including CRP, IL-6, ICAM-1, MMP-3, and VEGF. The drug is approved in Europe for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
