Celltrion's Stekima Secures IV Formulation Approval in Japan, Adds Crohn's Disease Indication

Entering Japan's IBD Market, Where Ustekinumab Accounts for 97% of Sales

Celltrion is accelerating its efforts to penetrate the inflammatory bowel disease (IBD) market in Japan by securing additional regulatory approval for the intravenous (IV) formulation of its autoimmune disease treatment, Stekima.

Product image of Celltrion's autoimmune disease treatment 'Stekima'. Celltrion

On April 21, Celltrion announced that it had received marketing authorization from Japan's Ministry of Health, Labour and Welfare for the IV formulation of 'Stekima (STEQEYMA)', a biosimilar containing ustekinumab.

With this latest approval, the Crohn's disease indication has been added to the existing subcutaneous (SC) formulation indications for psoriasis and psoriatic arthritis. The ability to choose the method of administration is regarded as expanding flexibility in prescriptions based on the characteristics of individual patients.

The Japanese ustekinumab market is structured so that approximately 97% of sales are concentrated in IBD. Celltrion expects to expand its market share by entering this high-demand segment through the addition of the Crohn's disease indication. The company also plans to complete its full-label strategy by adding the ulcerative colitis indication in the future.

The performance of existing products is also serving as a foundation. The breast cancer treatment Herzuma and the anticancer drug Begzelma have achieved market shares of 76% and 58%, respectively, in Japan. The autoimmune disease treatments Remsima and Yuflyma also maintain strong prescription shares among biosimilars, with 43% and 17%, respectively.

Celltrion is also working to diversify its portfolio in Japan by launching follow-up products such as the ophthalmic disease treatment Eydenzelt and the allergy treatment Omriclo.

This content was produced with the assistance of AI translation services.