EMA Approves GOTENFIA Biosimilar Golimumab, Expanding Affordable Treatment Options for Autoimmune Diseases in Europe
Published: 11 Mar 2026
Author: Precedence Research
European health authorities have granted approval for GOTENFIA (golimumab), a biosimilar monoclonal antibody developed by Bio-Thera Solutions and commercialized in Europe by STADA Arzneimittel AG. The product received marketing authorization from the European Medicines Agency, marking an important step in expanding treatment options for patients living with chronic inflammatory diseases. GOTENFIA is a biosimilar to Simponi, an established biologic therapy originally developed by Johnson & Johnson. It is indicated for the treatment of several immune-mediated conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The therapy works by blocking tumor necrosis factor-alpha (TNF-α), a protein that plays a key role in driving inflammation and immune system activity in these disorders.
The approval is considered a notable development in Europe’s growing biosimilars landscape, particularly within the TNF-α inhibitor category, which remains one of the largest and most widely used segments of biologic medicines worldwide. By introducing a biosimilar version of golimumab, healthcare providers across Europe may gain access to a more cost-effective alternative to the reference product while maintaining similar standards of safety and clinical effectiveness. Biosimilars are designed to closely match the original biologic therapy in terms of quality, efficacy, and safety, but are typically offered at lower prices, which can help healthcare systems manage the rising costs associated with long-term biologic treatments.
Under the strategic collaboration between Bio-Thera Solutions and STADA, Bio-Thera will oversee the development, manufacturing, and supply of the biosimilar product. Meanwhile, STADA will manage commercialization and distribution across key markets, including the European Union, the United Kingdom, Switzerland, and other international regions. This partnership combines Bio-Thera’s expertise in biologics research and manufacturing with STADA’s well-established commercial network in Europe, enabling faster introduction and broader availability of the therapy across multiple healthcare systems.
The approval of GOTENFIA also reflects a broader trend within the pharmaceutical industry. As patents for several blockbuster biologic medicines begin to expire, pharmaceutical companies are increasingly investing in the development of monoclonal antibody biosimilars. These products are expected to intensify market competition while improving affordability and patient access to advanced therapies. With strong regulatory support and growing confidence among physicians in prescribing biosimilars, treatments like golimumab biosimilars are likely to play an expanding role in managing chronic inflammatory diseases and improving access to biologic care across Europe.
According to Precedence Research, the biologics and biosimilars market size accounted for USD 610.41 billion in 2025 and is predicted to increase from USD 700.76 billion in 2026 to approximately USD 2,426.85 billion by 2035 expanding at a CAGR of 14.80% from 2026 to 2035 as demand grows for Biologics, monoclonal antibodies, and immunotherapies revolutionize cancer care, boosting survival and minimizing side effects.
The approval of GOTENFIA® by European regulators strengthens the biosimilars landscape by introducing a cost-effective golimumab therapy for the treatment of chronic inflammatory diseases across Europe.