CHMP backs label expansion to cover Crohn's disease and ulcerative colitis in children aged 2 and older

Auto-injector convenience and broader pediatric prescribing expected to lift Celltrion's European market share

Interleukin inhibitor additions deepen Celltrion's autoimmune portfolio beyond TNF-α franchise

Celltrion headquarters. [Celltrion]
Celltrion headquarters. [Celltrion]

Celltrion's Steqeyma (CT-P43, ustekinumab), a biosimilar of the autoimmune drug Stelara, has received a recommendation to expand its approved use in Europe to cover pediatric patients with inflammatory bowel disease.

Celltrion said Monday that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) issued a positive opinion recommending approval of a label change to add pediatric Crohn's disease and pediatric ulcerative colitis as indications for Steqeyma.

Following the CHMP recommendation, Celltrion will seek final authorization from the European Commission, which would allow Steqeyma to be prescribed to pediatric patients aged 2 and older across Europe. The company said it expects the expansion to open new treatment options for young patients, who have had limited choices compared with adults despite the importance of early intervention for healthy development.

Celltrion already supplies Steqeyma in Europe across a range of indications, including plaque psoriasis in adults and children, psoriatic arthritis in adults, Crohn's disease in adults, Crohn's disease in pediatric patients weighing 40 kilograms or more, and ulcerative colitis in adults. Extending eligibility to children aged 2 and older is expected to further strengthen the company's position in the European ustekinumab market.

Steqeyma has been rolling out in major markets — including the United States, Japan and Australia — since last year and has continued to gain traction. In Europe, the company has been growing prescriptions by highlighting the convenience of an auto-injector formulation it began supplying in the second quarter of this year. In the US market, valued at about 20 trillion won ($14.9 billion), Steqeyma's market share climbed from 10.2 percent in February to 16.2 percent in July.

Celltrion is diversifying its autoimmune portfolio by adding interleukin (IL) inhibitors such as Steqeyma and Abtoszma alongside its existing tumor necrosis factor-alpha (TNF-α) inhibitor lineup, which includes the Remsima family and Yuflyma. The company said its market position is expected to strengthen further as biosimilars of Cosentyx (CT-P55), Taltz (CT-P52) and Tremfya (CT-P68) enter the market in sequence.

Stelara is a blockbuster drug that recorded global sales of approximately $6.08 billion last year. According to IQVIA, the global ustekinumab market was valued at approximately $18.67 billion as of 2025.

"This positive opinion will help improve treatment access for pediatric patients in Europe," a Celltrion official said. "We will complete the remaining regulatory steps without delay and continue expanding our interleukin inhibitor pipeline to firmly establish our leadership in the global autoimmune disease market."

With the recommendation, Celltrion said it aims to establish a prescribing base spanning all age groups by entering the underserved pediatric inflammatory bowel disease segment ahead of competitors, and to consolidate its competitive edge in the European biosimilar market.


silverpaper@heraldcorp.com