Celltrion’s Steqeyma Recommended for Expanded Pediatric Indications in Europe

Celltrion announced on November 9 that its biosimilar Steqeyma (ustekinumab) has received positive recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for expanded indications targeting pediatric Crohn's disease and ulcerative colitis. If the European Commission grants final approval, Steqeyma will be available to patients aged 2 and older with Crohn's disease and ulcerative colitis in Europe.

Steqeyma is already approved for various indications, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults and children. The expanded recommendation aims to improve treatment options for pediatric patients, particularly those requiring timely treatment during growth and development. Since its launch last year, Steqeyma has been available in major markets such as Europe, the United States, Japan, and Australia.

In Europe, Celltrion introduced an autoinjector formulation in the second quarter of the year, which enhances convenience for patients and aids market expansion. Steqeyma has gained significant market share in the U.S. ustekinumab market, reaching 16.2% by July. The global ustekinumab market, valued at approximately $18.665 billion in 2025, remains substantial.

Celltrion is expanding its autoimmune disease portfolio beyond Steqeyma, currently marketing TNF-alpha inhibitors like Remsima and Yuflyma, and developing additional interleukin (IL) inhibitor biosimilars. The company's pipeline includes biosimilars referencing Cosentyx, Taltz, and Tremfya, anticipating these products to strengthen its position in the global autoimmune disease treatment market.