Japanese regulatory authorities have granted marketing approval for ‘NIPRO’—a biosimilar referencing Stelara (ustekinumab) developed by Samsung Bioepis—aiming to provide high-quality, affordable therapeutic options for patients.
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Approved Indications: The drug is authorized in a 45mg subcutaneous injection syringe format for the treatment of plaque psoriasis and psoriatic arthritis.
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Mechanism of Action: As a monoclonal antibody, it prevents the abnormal regulation of IL-12 and IL-23 cytokines, which are key drivers in immune-mediated inflammatory diseases.
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Commercialization Timeline: The product is scheduled for listing on Japan’s National Health Insurance (NHI) drug list in May 2026, with NIPRO handling immediate commercial distribution thereafter.
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Global Footprint: This approval reinforces Samsung Bioepis’ position as a biosimilar leader, with its ustekinumab formulation already authorized in major markets including the US, Europe, Canada, Korea, the UK, and Australia.
Source: https://www.contractpharma.com/breaking-news/samsung-bioepis-stelara-biosimilar-approved-in-japan/