Shots:
- 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 2026
- 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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