Celltrion is strengthening its position in the global market by expanding the range of conditions treated with its biosimilars.
The company said Monday that SteQeyma (development code CT-P43), its biosimilar to Stelara (ustekinumab), has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for expanded indications covering pediatric Crohn's disease and pediatric ulcerative colitis.
SteQeyma is currently approved in Europe for several indications, including plaque psoriasis in adults and children, psoriatic arthritis in adults, Crohn's disease in adults and children weighing at least 40 kilograms, and ulcerative colitis in adults.
If the European Commission grants final approval following the recommendation, SteQeyma will be available for treating inflammatory bowel diseases in children aged 2 and older, further strengthening Celltrion's market position.
SteQeyma has been launched sequentially in major markets, including Europe, the United States, Japan and Australia, since last year, gaining traction in the global ustekinumab market.
Its sales have grown rapidly, particularly since Celltrion began supplying an autoinjector formulation in Europe in the second quarter of this year, offering greater convenience for patients. The company expects its influence in the European market to expand further.
In the U.S. ustekinumab market, valued at approximately 20 trillion won, SteQeyma secured a 16.2 percent market share just over a year after its launch, maintaining its position among the leading biosimilars, according to IQVIA data for July.
Celltrion continues to expand its autoimmune disease treatment portfolio, ranging from tumor necrosis factor alpha (TNF-α) inhibitors, including its Remsima product line and Yuflyma, to interleukin (IL) inhibitors such as SteQeyma and Aptozma.
The company is also developing several next-generation IL inhibitors, including CT-P55, a biosimilar to Cosentyx; CT-P52, a biosimilar to Taltz; and CT-P68, a biosimilar to Tremfya. These efforts are expected to further strengthen its autoimmune disease portfolio.
A Celltrion official said the positive recommendation for the expanded indications is expected to improve treatment opportunities for pediatric patients in Europe.
"We will proceed with the remaining regulatory steps without delay to further expand SteQeyma's treatment indications. We will also continue broadening our next-generation interleukin inhibitor lineup, building on our existing flagship products, to further strengthen our position in the global autoimmune disease market," the official said.
in THEBIO
