The European Commission has approved STADA and Bio-Thera Solutions’ Gotenfia, a biosimilar to Johnson & Johnson’s Simponi, clearing the way for its rollout across the European Union and European Economic Area.

The authorization covers multiple chronic inflammatory autoimmune conditions and follows a positive recommendation issued in December 2025 by the European Medicines Agency’s Committee for Medicinal Products for Human Use. STADA said launch preparations are underway, with product availability expected in the coming weeks.

Gotenfia, developed by Bio-Thera as BAT2506, becomes the second Simponi biosimilar authorized in Europe, a development expected to increase pricing pressure in the anti-TNF market and broaden patient access.

“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,” commented STADA’s Global Specialty Head, Bryan Kim. “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.”

Bio-Thera CEO Shengfeng Li said, “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.”

Regulators based their decision on analytical, nonclinical, and clinical data demonstrating biosimilarity to Simponi. The authorization covers 50mg/0.5mL and 100mg/mL pre-filled syringes with passive needle safety guards.

STADA and Bio-Thera entered a licensing and commercialization deal for BAT2506 in May 2024. Bio-Thera oversees development, manufacturing, and supply, while STADA holds exclusive commercialization rights in the EU, the UK, Switzerland, and other selected markets. The companies expanded their partnership in 2025 to include a biosimilar to tocilizumab, which is also preparing for launch.