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Samsung Bioepis Launches Ustekinumab Biosimilar in Japan

Marks first product launch in Japan.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Samsung Bioepis Co. Ltd. has launched Ustekinumab BS 45 mg Syringe for S.C. Injection (NIPRO), a biosimilar referencing Stelara (ustekinumab)—its first product launch in Japan.

“We are thrilled to announce the launch of our first biosimilar product in Japan in partnership with NIPRO,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets at Samsung Bioepis. “Together with our partner NIPRO, we look forward to supporting patients living with autoimmune diseases and contributing to the sustainability of Japan’s healthcare system by providing quality-assured, safe and effective biosimilar options.”

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. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted marketing authorization to Ustekinumab BS 45 mg Syringe for S.C. Injection(NIPRO) for the treatment of plaque psoriasis and psoriatic arthritis in December 2025.

Samsung Bioepis’s ustekinumab biosimilar is also available under different brand names across the European Union, Korea, the United Kingdom and the United States.

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