Samsung Bioepis, a South Korea-based company, has launched its ustekinumab biosimilar in Japan through its partnership with Nipro Corporation, expanding access to biologic treatments for immune-mediated conditions.
- Product Details: The biosimilar references Stelara (ustekinumab) and is approved in Japan for the treatment of plaque psoriasis and psoriatic arthritis.
- Commercial Availability: The product is marketed in Japan following inclusion in the National Health Insurance (NHI) Drug Price Standard, effective from 20 May 2026.
- Regulatory Status: The biosimilar received marketing authorisation from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025.
This summary is based on a news article issued by BioSpectrum Asia.
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