Celltrion's Steqeyma Advances for Pediatric IBD in Europe
A positive CHMP opinion recommends expanding Steqeyma's use to pediatric Crohn's disease and ulcerative colitis.
Updated on Nov. 9, 2026 in Healthcare
Celltrion received a positive opinion from the European Medicines Agency's CHMP for its ustekinumab biosimilar Steqeyma, covering pediatric Crohn's disease and pediatric ulcerative colitis. The European Commission must still issue a final decision before the indication takes effect.
Why it matters
The opinion would extend Steqeyma's prescribing scope to younger patients with inflammatory bowel disease, a population previously limited in ulcerative colitis treatment options. For the biosimilar market, it signals continued expansion of ustekinumab alternatives across European pediatric care.
Stelara posted about 6.078 billion dollars in 2025 global sales, within an ustekinumab market estimated at 18.665 billion dollars per IQVIA. The European Commission's final decision on the pediatric indication remains pending.
The players
Celltrion
Celltrion is a South Korean biopharmaceutical company that develops and markets biosimilars, including Steqeyma.
European Medicines Agency
The European Medicines Agency is the EU body responsible for the scientific evaluation of medicines, and its CHMP issues opinions on marketing authorizations.
The details
Under the existing European approval, Steqeyma is usable for pediatric Crohn's disease patients weighing 40 kg or more, while ulcerative colitis use had been limited to adults. The CHMP opinion, announced on November 9, 2026, would extend the indication to both conditions for patients aged two years and older.
Timeline
November 9, 2026: Celltrion announces the CHMP positive opinion for pediatric Crohn's disease and ulcerative colitis.
Q2 2026: Celltrion begins supplying an auto-injector formulation of Steqeyma in Europe.
2025: Stelara global sales and the ustekinumab market size are recorded.
Market Landscape
The opinion extends biosimilar competition against Stelara, whose 2025 global sales of about 6.078 billion dollars sit within an ustekinumab market estimated at 18.665 billion dollars. Pediatric inflammatory bowel disease represents a new segment where biosimilar entrants can compete.
If approved, families of children with Crohn's disease or ulcerative colitis aged two and older would gain a biosimilar option for ustekinumab therapy. Prescribing would still depend on physician evaluation and the final European Commission decision.
The takeaway
Biosimilar expansion into pediatric indications can broaden treatment access, but the timing depends on regulatory steps that follow an EMA opinion. Patients and caregivers should confirm current availability with their treating clinicians.
What happens next
The European Commission's final decision on the pediatric indication for Steqeyma is pending and will determine when prescribing begins.
Further reading
Explore more on Healthcare developments shaping biosimilar access worldwide.
