[Edaily Reporter KIM SAE-MI ] Celltrion ( Celltrion(068270)) is seeking to expand the indication for its autoimmune disease treatment “Stekima” (active ingredient: ustekinumab) to include pediatric inflammatory bowel disease in Europe.

Celltrion announced on the 9th that Stekima received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for a marketing authorization variation to add indications for Crohn’s disease and ulcerative colitis in children aged 2 years and older.

Stekima is a biosimilar (a copy of a biologic drug) of Janssen’s autoimmune disease treatment “Stelara.” Celltrion currently markets Stekima in Europe for indications including plaque psoriasis in adults and children, psoriatic arthritis in adults, Crohn’s disease in adults, Crohn’s disease in children weighing 40 kg or more, and ulcerative colitis in adults.

Following this approval recommendation, once final approval is granted by the European Commission (EC), the prescription eligibility for Stekima will be expanded to include pediatric patients aged 2 years and older with inflammatory bowel disease. This is expected to improve access to treatment for pediatric patients by broadening the prescription scope beyond the previous weight restrictions.

Stekima has been launched sequentially in major markets, including Europe, the United States, Japan, and Australia, since last year. In the second quarter of this year, the company began supplying the autoinjector (AI) formulation in Europe, enhancing the convenience of administration.

It is also expanding its market share in the U.S. According to Celltrion, Stekima’s share of the U.S. ustekinumab market rose by 6 percentage points (p) in just five months, from 10.2% in February to 16.2% in July of this year.

The original drug, Stelara, recorded global sales of approximately $6.078 billion (approximately 8.5092 trillion won) last year. According to the pharmaceutical market research firm IQVIA, the global ustekinumab market was estimated to be worth approximately $18.66538 billion (approximately 26.1315 trillion won) last year.

Following its existing tumor necrosis factor-alpha (TNF-α) inhibitor product line—including the Remsima product family and Uplima—Celltrion is expanding its lineup of interleukin (IL) inhibitors, such as Stekima and Aptozma. The company is also developing biosimilars of Cosentyx (CT-P55), Talz (CT-P52), and Tremfya (CT-P68) as follow-on products.

A Celltrion spokesperson stated, “Based on this recommendation for approval of additional indications, we expect to contribute to expanding treatment opportunities for pediatric patients in Europe in the future,” adding, “We will proceed smoothly with the remaining approval procedures to further broaden Stekima’s scope of treatment and continue to expand our pipeline of interleukin inhibitors, thereby further solidifying our position in the global autoimmune disease market.”