On 1 May 2026, Janssen/Johnson & Johnson (J&J) announced that, on 15 April 2026, the FDA approved Stelara® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease. Stelara® is now the only FDA-approved IL-12/23 antagonist and the first non-TNF biologic to treat adults and children with moderately to severely active Crohn’s disease.
The approval is based on data from the Phase 3 UNITI-Jr clinical study, a multi-centre interventional study to evaluate the efficacy, safety, and pharmacokinetics of Stelara® for the treatment of paediatric Crohn’s disease over 52 weeks.
Stelara® is facing significant competition from biosimilars globally, including in the US, following settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in the US in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Samsung Bioepis’/Sandoz’s Pyzchiva® (February 2025), Celltrion (Steqeyma® launched March 2025) and Fresenius Kabi and Formycon (Otulfi® launched March 2025). Other ustekinumab biosimilars launched in the US include Dong A-ST/Accord’s Imuldosa® (August 2025) and Bio-Thera/Hikma’s Starjemza™ (November 2025).