On 13 February 2026, STADA and Bio-Thera Solutions announced that the European Commission has granted marketing authorisation for Gotenfia®, biosimilar to Janssen’s Simponi® (golimumab). According to the announcement, plans are underway to launch Gotenfia® in Europe “in the coming weeks and months”.
Gotenfia® received a positive recommendation from the EMA’s CHMP in December 2025 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis. It is the second golimumab biosimilar to be approved in Europe, following the approval of Alvotech/Advanz’s Gobivaz® in November 2025.
Gotenfia®/BAT2506 was developed by Bio-Thera and is being commercialised by STADA in Europe under a May 2024 agreement.