On 9 June 2025, Celltrion announced that its Qoyvolma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC). Qoyvolma® is Celltrion’s second European ustekinumab biosimilar, following Steqeyma®, which was approved by the EC in August 2024 and launched in the EU in November 2024.
Qoyvolma® received a positive opinion from the EMA’s CHMP in March 2025. It has been approved with an additional indication to that of Steqeyma®, with moderately to severely active ulcerative colitis in adults included in its list of indications, together with adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.
There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024. 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).