Celltrion wins FDA, Health Canada nods for pediatric Stelara biosimilar vial

Celltrion has picked up additional approvals from the FDA and Health Canada for its biosimilar to Janssen’s Stelara, Steqeyma (CT-P43), clearing a 45mg/0.5mL vial formulation for pediatric autoimmune indications, the company said Monday.

The new vial expands Steqeyma’s North American lineup to four dosing options. It joins the 45mg and 90mg prefilled syringes and the 130mg/26mL vial, enabling weight-based dosing for pediatric patients who require more precise treatment.

The latest authorizations follow initial approvals in Canada in July and in the U.S. in December 2024. In Canada, Steqeyma recently received a nod for the pediatric plaque psoriasis indication, allowing full-label marketing in both countries.

Celltrion is positioning Steqeyma to broaden its North American autoimmune portfolio, which includes Remsima (infliximab), Zymfentra (subcutaneous infliximab), and Yuflyma (adalimumab).

The global ustekinumab market reached $21.7 billion in 2024, according to IQVIA, with the U.S. accounting for $16.7 billion and Canada for $647.8 million, together representing roughly 80 percent of the total.