On 18 December 2025, Celltrion announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of an autoinjector (pre-filled pen) form of Steqeyma® and Qoyvolma®, biosimilars to J&J/Janssen’s Stelara® (ustekinumab). The CHMP also recommended Qoyvolma® for a 45 mg vial formulation, such that Celltrion will have a “full lineup” of both products with all dosages and formulations of Stelara®.
According to Celltrion, the autoinjector device includes a viewing window and audible indicators to enable patients to easily identify the injection status and has “special thin-wall needle technology to help reduce injection pain”.
The positive EU opinion for the autoinjector presentation of Celltrion’s ustekinumab biosimilars, comes just days after Celltrion received approval for the same presentation of Steqeyma® in Australia.
Steqeyma® was first approved in the EU in September 2024 in a pre-filled syringe (45mg/0.5mL, 90mg/1mL) and vial (45mg/0.5mL) for subcutaneous injection, as well as 130mg/26mL concentrate for intravenous infusion. It was launched in the EU in November 2024 and is indicated for adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease. Qoyvolma® received EU marketing approval in June 2025, with an additional indication to that of Steqyema®, being moderately to severely active ulcerative colitis in adults.
Ustekinumab biosimilars already being commercialised in Europe include STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva®, both launched in July 2024. Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).