Celltrion’s Steqeyma gets European backing for pediatric Crohn’s, colitis use

Nov 9, 2026 00:32 (15h ago)

Celltrion said CHMP recommended expanding Steqeyma’s European use to pediatric Crohn’s disease and ulcerative colitis patients.
Steqeyma’s U.S. ustekinumab market share rose to 16.2% in July from 10.2% in February.
European Commission approval would be required before the pediatric label expansion takes effect.

Celltrion said its autoimmune treatment Steqeyma is moving toward a broader European prescribing label after the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s medicines committee, recommended adding Crohn’s disease and ulcerative colitis indications for children aged 2 and older. Steqeyma is a biosimilar, or highly similar version of a biologic drug, containing ustekinumab and referencing Stelara. Final approval by the European Commission would expand access to pediatric patients, who currently have few treatment options. The company already holds European approval for several adult and pediatric uses, while Steqeyma has been available since last year in Europe, the United States, Japan and Australia. Its U.S. share of the ustekinumab market rose to 16.2% in July from 10.2% in February. Celltrion is also broadening its autoimmune portfolio beyond TNF-α inhibitors to IL inhibitors and additional biosimilars.