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The MHLW has granted marketing approval to Ustekinumab BS IV infusion 130mg 「NIPRO」, a biosimilar version of Stelara (ustekinumab), for induction therapy in mod. to sev. active Crohn’s disease when other treatments are ineffective
Additionally, the MHLW approved Ustekinumab BS SC Injection 45mg Syringes 「NIPRO」in Dec 2025, which was then launched in May 2026Â
The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing & commercializing multiple biosimilars in Japan, incl. ustekinumab
Ref: Samsung Bioepis | Image: Samsung Bioepis | Press Release
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The post Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar appeared first on PharmaShots.
