Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan 

Shots: 

• Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation 

• Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026  

• It is also approved in Australia, Brazil, Canada, Europe, Korea, Switzerland, the UK, and the US 

Ref: Samsung Bioepis | Image: Samsung Bioepis | Press Release

Related News: Samsung Bioepis Enters Asset Purchase Deal with Biogen for Byooviz (Biosimilar, Lucentis) and Opuviz (Biosimilar, Eylea) in the EU

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