On 2 April 2025, Johnson & Johnson announced that the European Commission has approved Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.
This follows the adoption of a positive opinion by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for this indication of Stelara® in February 2025.
There are a number of ustekinumab biosimilars marketed in the EU, with three launched during 2024: STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024. Previously approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).