Samsung Bioepis has obtained the advertising approval in Japan of Ustekinumab BS Subcutaneous Injection 45mg Syringes NIPRO, a biosimilar referencing Stelara (ustekinumab), developed by Samsung Bioepis, the corporate introduced on Dec. 23. That is the primary product to realize advertising approval in Japan beneath the partnership with NIPRO Corp. entered in June 2025.
“Japan allocates about 10% of its GDP to healthcare, one of many highest amongst OECD international locations which is why biosimilars are taking part in an more and more vital position in assuaging the monetary burden for Japan’s healthcare system. With this biosimilar approval, we’re paving the best way for increasing entry to high-quality, reasonably priced therapy choices for sufferers with autoimmune circumstances,” mentioned Jung Byoun-gin, vice chairman and Regulatory Affairs Crew chief at Samsung Bioepis. “As a confirmed biosimilar chief, we stay dedicated to delivering quality-assured biologics that help higher take care of sufferers and strengthen healthcare methods around the globe.”
Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that forestalls irregular regulation of IL-12 and IL-23 related to immune-mediated ailments. NIPRO has been accredited for the therapy of plaque psoriasis, and psoriatic arthritis. The product is ready to be listed within the Japan’s Nationwide Well being Insurance coverage (NHI) drug checklist in Might 2026, permitting for commercialization by NIPRO instantly after drug itemizing.
Samsung Bioepis’s ustekinumab can be accredited and accessible throughout Australia, Brazil, Canada, Europe, Korea, Switzerland, the UK, and the USA.
