Celltrion announced on Tuesday that it has received approval from Japan’s Ministry of Health, Labour and Welfare for the intravenous (IV) formulation of its autoimmune disease treatment, Steqeyma (ustekinumab).
This approval significantly expands Celltrion’s treatment options, adding Crohn’s disease (CD) to the existing indications for psoriasis and psoriatic arthritis covered by the subcutaneous (SC) formulation.
The new formulation enhances Steqeyma’s competitiveness by allowing for tailored prescriptions based on administration settings and individual patient needs.
In Japan, the ustekinumab market is dominated by the inflammatory bowel disease (IBD) sector, accounting for about 97% of total revenue. By securing approval for CD, which represents nearly half of this market, Celltrion aims to rapidly increase its share in the lucrative IBD market.
The company plans to further strengthen its position in Japan’s ustekinumab market by seeking approval for ulcerative colitis indications, aiming to offer a full-label product.
Celltrion has established itself as a market leader in Japan with its cancer and autoimmune disease treatments.
As of December last year, its breast cancer drug Herjuma held a 76% market share, maintaining its top position in trastuzumab prescriptions for four and a half years. Its successor, Vegzelma, has also captured a 58% market share.
In the autoimmune disease sector, Remsima and Yuflyma have achieved market shares of 43% and 17% respectively, leading prescription volumes among biosimilars.
Building on these successes, Celltrion plans to expand its influence in the Japanese market by launching new products, including the recently approved ophthalmic treatment Idenselt and allergy medication Omlyclo.
A Celltrion spokesperson stated that the approval of Steqeyma’s IV formulation allows us to broaden its treatment scope and target the high-demand IBD market in Japan. It will leverage our proven track record and expertise to accelerate growth in Japan and translate this success to the global market.