Celltrion's SteQeyma Receives "Positive Recommendation" for Pediatric Bowel Disease Indications in Europe

Awaiting final EC approval

Celltrion’s autoimmune disease treatment SteQeyma (generic name: ustekinumab) has cleared a path to expand its eligible patient population in Europe to include children aged 2 and older with intestinal diseases. The move is expected to improve access to timely treatment for pediatric patients, who need care to support their growth and development.

A view of Celltrion in Yeonsu-gu, Incheon. The Asia Business Daily archive.

On November 9, Celltrion said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of a variation to add indications for pediatric Crohn’s disease and pediatric ulcerative colitis. If the European Commission (EC) grants final approval, SteQeyma will be available in Europe to patients aged 2 and older.

SteQeyma is a biosimilar to Stelara. In Europe, it is already used to treat plaque psoriasis in adults and children, psoriatic arthritis in adults, Crohn’s disease in adults and children weighing at least 40 kg, and ulcerative colitis in adults. Celltrion has also boosted sales by supplying an autoinjector formulation in Europe since the second quarter of this year.

SteQeyma is also gaining ground in the U.S. ustekinumab market, which is worth about 20 trillion won. In February this year, about a year after launch, it reached a 10.2% market share; by July, it had risen to 16.2%, a 6-percentage-point increase in five months. Global sales of the original drug, Stelara, totaled about $6.078 billion last year.

Celltrion is expanding its autoimmune disease portfolio beyond tumor necrosis factor (TNF-α) inhibitors such as Remsima and Yuflyma to interleukin (IL) inhibitors such as SteQeyma and Aptozma. It is also developing biosimilars to Cosentyx, Taltz, and Tremfya.

A Celltrion representative said, "We expect this positive recommendation to help expand treatment opportunities for pediatric patients in Europe. We will proceed with the remaining approval steps without disruption and add more follow-on interleukin inhibitors to further strengthen our position in the global autoimmune disease market."

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