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[IT뉴스]Celltrion’s Steqeyma Wins EU Backing for Pediatric IBD Expansion

온카뱅크관리자

2026-11-09 09:27:26

Targets Crohn’s and colitis in children aged 2 and older Final EU approval pending; broader access expected U.S. market share rises 6 percentage points to 16.2% 
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 [Kim Saemi, Edaily Reporter] Celltrion is moving to expand the European indications of its autoimmune disease treatment Steqeyma (ustekinumab) to include pediatric inflammatory bowel disease (IBD).
 The South Korean biopharmaceutical company said Monday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of an indication extension for Steqeyma to treat Crohn’s disease and ulcerative colitis in children aged 2 and older.
 Steqeyma is a biosimilar version of Janssen’s blockbuster autoimmune disease treatment Stelara. It is currently marketed in Europe for plaque psoriasis in adults and children, psoriatic arthritis in adults, Crohn’s disease in adults and pediatric patients weighing at least 40 kilograms, and ulcerative colitis in adults.
 If the European Commission grants final approval, Steqeyma’s eligible patient population will expand to include children aged 2 and older with inflammatory bowel disease. The expanded indications are expected to improve treatment access by removing existing weight-related restrictions for certain pediatric patients.
 Steqeyma has been rolled out across major markets, including Europe, the United States, Japan and Australia, since last year. In the second quarter of 2026, Celltrion introduced an autoinjector formulation in Europe to improve convenience for patients.
 The product has also been gaining ground in the U.S. market. According to Celltrion, Steqeyma’s share of the U.S. ustekinumab market rose from 10.2% in February to 16.2% in July, an increase of 6 percentage points over five months.
 The original drug, Stelara, generated approximately $6.08 billion in global sales last year. According to pharmaceutical market research firm IQVIA, the global ustekinumab market was estimated at approximately $18.67 billion in 2025.
 Celltrion has been expanding its autoimmune disease portfolio beyond tumor necrosis factor-alpha (TNF-α) inhibitors, including the Remsima franchise and Yuflyma, into interleukin (IL) inhibitors such as Steqeyma and Avtozma.
 The company is also developing biosimilars of Cosentyx (CT-P55), Taltz (CT-P52) and Tremfya (CT-P68) to further strengthen its interleukin inhibitor pipeline.
 “We expect the CHMP’s positive recommendation to help expand treatment opportunities for pediatric patients in Europe,” a Celltrion official said.
 “We will work to complete the remaining regulatory procedures without delay, broaden Steqeyma’s treatment indications and continue expanding our next-generation interleukin inhibitor portfolio to further strengthen our position in the global autoimmune disease market,” the official added.
 김새미 (bird@edaily.co.kr) 
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