On February 13, 2026, STADA and Bio-Thera announced that they have received European Marketing Authorization for GOTENFIA®, a golimumab biosimilar to Johnson & Johnson’s SIMPONI®. GOTENFIA® is a human monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α), a key driver of inflammation in multiple autoimmune conditions. GOTENFIA® has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Bio-Thera is responsible for development, manufacture, and supply, while STADA holds exclusive rights to commercialization of the product in the E.U., the U.K., Switzerland, and other countries. Bio-Thera has partnered with Accord Biopharma for its golimumab biosimilar for the U.S. market, where its Biologics License Application remains under review by the FDA.
Additionally, on February 23, 2026, Sandoz and Lupin announced that they have received European Marketing Authorization for RANLUSPEC®, a ranibizumab biosimilar to Genentech’s LUCENTIS®. RANLUSPEC® is approved for the treatment of neovascular (wet) age-related macular degeneration and other retinal vascular disorders. Lupin is responsible for the development, manufacture, and registration of the product, while Sandoz holds exclusive commercialization rights for the product across the European Union, excluding Germany, and semi-exclusive rights in France.
Stay tuned to Big Molecule Watch as we continue to monitor updates in the European biosimilars industry.