Celltrion said on the 21st that it won approval from Japan's Ministry of Health, Labour and Welfare for the intravenous (IV) formulation of the autoimmune disease treatment "Steqeyma" (ingredient name ustekinumab).
Steqeyma is a biosimilar of "Stelara," an inflammatory autoimmune disease treatment developed by Johnson & Johnson (J&J) subsidiary Janssen in the United States. With this IV formulation approval, Crohn's disease (CD) has been added as a treatment indication in addition to the existing subcutaneous (SC) formulation used for psoriasis and psoriatic arthritis, expanding the treatment scope.
Crohn's disease is a chronic inflammatory bowel disease (IBD) that can occur throughout the digestive tract. In Japan, about 97% of ustekinumab sales are concentrated in IBD. By securing the Crohn's disease indication, which accounts for about half of that, Celltrion established a foothold to enter a high-demand market. The company plans to further strengthen its position in Japan by adding ulcerative colitis as a treatment indication in the future.
Steqeyma has entered the global market with sequential launches in major countries including Japan, the United States, Europe, and Australia. According to pharmaceutical market research firm IQVIA, the global ustekinumab market in 2025 is estimated at about $18.6 billion (about 27.9 trillion won).
Celltrion has expanded its market share in Japan with existing products. The breast cancer treatment "Herzuma" holds the top prescription share for trastuzumab at 76%, and "Vegzelma" stands at 58%. The autoimmune disease treatments "Remsima" and "Yuflyma" recorded market shares of 43% and 17%, respectively.
Building on these results, the company is also pushing to launch follow-up products such as the ophthalmic disease treatment "Eydenzelt" and the allergy disease treatment "OMLYCLO."
A Celltrion official said, "With this IV formulation approval, Steqeyma's treatment area has expanded," adding, "We will strengthen our push into Japan's high-demand IBD market and carry that momentum into global results."