Celltrion (068270.KS) is accelerating its push into the Japanese market after securing additional approval for the intravenous (IV) formulation of its autoimmune disease treatment Steqeyma (ustekinumab).
Celltrion said Tuesday that it has obtained marketing authorization from Japan's Ministry of Health, Labour and Welfare for the IV formulation of Steqeyma. The approval adds Crohn's disease (CD) as an indication, following the earlier subcutaneous (SC) formulation indicated for psoriasis and psoriatic arthritis.
In Japan's ustekinumab market, approximately 97% of total sales are concentrated in the inflammatory bowel disease (IBD) segment. With about half of that accounted for by Crohn's disease, Celltrion plans to use this approval as a springboard to pursue an additional indication for ulcerative colitis and to accelerate its market share expansion.
As of December last year, Celltrion has been leading Japan's oncology and autoimmune disease treatment markets. Its breast cancer treatment Herzuma held a 76% market share, ranking first in trastuzumab prescriptions for four and a half years, while its autoimmune disease treatments Remsima and Yuflyma recorded the highest prescription volumes among biosimilars with 43% and 17% shares, respectively.
Building on the performance of these existing products, the company plans to sequentially launch follow-up pipeline products, including the ophthalmic disease treatment Eydenzelt and the allergy treatment Omlyclo, both of which received approval last month.
"Through this IV formulation approval, we have expanded the therapeutic scope of Steqeyma and can now fully target the IBD market, where demand is high in Japan," a Celltrion official said. "Based on the results we have demonstrated in Japan and the know-how we have accumulated, we will further strengthen our growth momentum."
