On 7 October 2025, Johnson & Johnson announced that the FDA has approved Simponi® (golimumab) for treating children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. The FDA approval follows J&J’s submission of the sBLA for this indication in December 2024.
Simponi® has previously been FDA approved for adults with moderately to severely active UC, moderate to severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.
The first golimumab biosimilar to be approved worldwide was Alvotech/Fuji Pharma’s AVT05, which received approval in Japan in September 2025. Earlier in September 2025, Alvotech/Advanz’s Gobivaz® received a positive opinion from the European Medicine Agency’s CHMP, after the European MAA for that product was the first golimumab MAA to be accepted anywhere in the world (November 2024). Alvotech/Teva’s Biologics Licence Application (BLA) for AVT05 was accepted by the FDA in January 2025, with approval expected in Q4/2025.
Bio-Thera/STADA’s MAA for the golimumab biosimilar BAT2506 was accepted by the EMA in February 2025, while Bio-Thera/Accord’s BLA for BAT2506 was accepted for FDA review in July 2025.