SamsungBioepisAnnouncesApprovalofUstekinumabBiosimilarinJapan
===2025/12/23 14:44:45===
l burden for Japan’s healthcare system. 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.”
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.
Samsung Bioepis&rsquo
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