Celltrion has launched the intravenous (IV) formulation of its autoimmune disease treatment, Stekima (ustekinumab), in Japan. Stekima is the only biosimilar of ustekinumab available in both IV and subcutaneous (SC) formulations in the country.
On August 21, Celltrion announced that it completed the local launch of the Stekima IV formulation approximately four months after receiving product approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) in April. The company has significantly expanded its treatment scope by adding Crohn's disease (CD) to the existing indications of psoriasis (PsO) and psoriatic arthritis (PsA).
Celltrion's Japan subsidiary plans to leverage its sales expertise gained from existing autoimmune products like Remsima (infliximab) and Yuflyma (adalimumab) to ensure the early market penetration of Stekima.
Currently, Celltrion's products hold a dominant market share in Japan. As of May this year, Remsima and Yuflyma recorded market shares of 46.9% and 19.5%, respectively, maintaining their positions as the top prescribed biosimilar products.
Stekima is the only biosimilar of ustekinumab available in both IV and SC formulations in Japan.
Patients can initiate treatment in the early stages of the disease with the IV formulation and manage the condition long-term using the SC formulation.
Celltrion's Japan subsidiary plans to actively promote the competitive advantages of Stekima to healthcare professionals at major conferences, including the Japanese Society of Gastroenterology (JDDW) and the Japanese Society of Inflammatory Bowel Disease (JSIBD), scheduled for the second half of the year.
A Celltrion official stated, "With the launch of the Stekima IV formulation, we now possess both formulations, giving us a differentiated advantage over competitors. We expect this will increase preference among Japanese healthcare professionals and patients."
The official added, "We will actively utilize the human network built through our existing product sales to facilitate the early market establishment of Stekima, thereby enhancing Celltrion's influence in the Japanese autoimmune disease market."
Meanwhile, Seo Jung-jin, Chairman of Celltrion Group, has embarked on a global management initiative this August to expand sales in key overseas markets, including Europe, the United States, Canada, and Japan.
Chairman Seo departed for Paris, France, on August 10 and is visiting major European countries before checking in on key overseas subsidiaries in the U.S., Canada, and Japan to review sales and revenue plans for the second half of the year. The company explained that this trip focuses on verifying the sales execution capabilities necessary to achieve the second-half revenue targets, rather than merely visiting overseas subsidiaries.
* This article has been translated by AI.
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