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Samsung Bioepis’ Stelara Biosimilar Approved in Japan

NIPRO has been approved for the treatment of plaque psoriasis, and psoriatic arthritis.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Samsung Bioepis Co. Ltd. has announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes ‘NIPRO’, a biosimilar referencing Stelara (ustekinumab), in Japan.

Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that prevents abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases. ‘NIPRO’ has been approved for the treatment of plaque psoriasis, and psoriatic arthritis. The product is set to be listed in the Japan’s National Health Insurance (NHI) drug list in May 2026, allowing for commercialization by NIPRO immediately after drug listing.

“With this biosimilar approval, we are paving the way for expanding access to high-quality, affordable treatment options for patients with autoimmune conditions,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “As a proven biosimilar leader, we remain committed to delivering quality-assured biologics that support better care for patients and strengthen healthcare systems around the world.”

Samsung Bioepis’s ustekinumab is also approved and available across Australia, Brazil, Canada, Europe, Korea, Switzerland, the United Kingdom, and the United States.

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