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Celltrion launches SteQeyma IV in Japan

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A patient beginning SteQeyma in Japan can now start with an intravenous infusion and move to a subcutaneous injection for maintenance. Celltrion has launched the IV formulation of its ustekinumab biosimilar, about four months after Japan’s Ministry of Health, Labour and Welfare approved it in April.

The change widens both the medicine’s reach and its treatment path. SteQeyma was already indicated for psoriasis and psoriatic arthritis; it now also covers Crohn’s disease, an inflammatory bowel disease. Celltrion says the IV option can be used during induction, when treatment begins, before switching to the SC — subcutaneous — formulation for ongoing care, depending on the disease stage and the patient’s condition.

Japan is not a blank market for Celltrion. As of May, its existing autoimmune products Remsima and Yuflyma held 46.9% and 19.5% of the Japanese biosimilar market, respectively, according to IQVIA and market data. The company’s Japanese subsidiary plans to reuse that sales expertise and its relationships with gastroenterologists and pharmacists to expand SteQeyma prescriptions.

In practical terms, the launch gives Japanese healthcare professionals another formulation choice and makes SteQeyma the only ustekinumab biosimilar available in Japan in both IV and subcutaneous versions, according to Celltrion. Patients may therefore be able to change the administration method between induction and maintenance without changing the product.

Celltrion will promote SteQeyma at Japan Digestive Disease Week and the Japanese Society for Inflammatory Bowel Disease later this year. It also plans to strengthen its doctor and pharmacist network ahead of the Japanese launch of Remsima SC next year. The company expects these commercial synergies to speed adoption; no independent assessment of that expectation is reported here.

46.9%Remsima’s share of Japan’s biosimilar market as of May

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