Global pharmaceutical companies STADA and Bio-Thera have won marketing authorization from the European Commission for Gotenfia, a biosimilar version of Simponi (golimumab), marking a significant development in treatment options for chronic inflammatory autoimmune diseases across Europe.
The approval enables STADA to commercialize Gotenfia in the European Union, the United Kingdom, Switzerland and several other markets, following regulatory review by the European Medicines Agency. Bio-Thera developed and will supply the product, while STADA will lead distribution and commercialization.
Gotenfia has been authorized for multiple indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis, among other inflammatory conditions. The approval positions Gotenfia as the second golimumab biosimilar available in the EU, adding competitive pressure in a segment with annual sales previously valued in the hundreds of millions of euros.
Preparations are now underway to introduce the therapy to patients in European markets in the coming weeks and months, with expectations that increased competition will broaden access to treatment and may help reduce costs for healthcare systems and patients.
Under the collaboration agreement between STADA and Bio-Thera, the biopharmaceutical partner retains responsibility for development, manufacturing and supply, while STADA holds exclusive commercial rights across the designated territories.
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