On 16 December 2024, Johnson & Johnson (J&J) announced that it submitted a supplemental Biologics Licence Application (sBLA) to the US FDA seeking the approval of Simponi® (golimumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC). This would add to the already approved indication of Simponi® for the treatment of adults with moderately to severely active UC.
This news follows Alvotech and Advanz Pharma’s announcement in November 2024 that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for their AVT05, biosimilar to Simponi® (golimumab), for treatment of several chronic inflammatory diseases. This is thought to be the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.