Samsung Bioepis and NIPRO launch Ustekinumab BS 45 mg Syringe in Japan following NHI listing, marking Bioepis’ first commercialized product in the country and expanding its global biosimilar footprint in immunology.
By: Regulatory Desk
Samsung Bioepis and NIPRO CORPORATION have announced the launch of Ustekinumab BS 45 mg Syringe for S.C. Injection NIPRO in Japan, marking Samsung Bioepis’ first commercialized product in the country under their strategic partnership. The rollout follows the product’s inclusion in Japan’s National Health Insurance (NHI) Drug Price Standard, which took effect on May 20 after publication in the Official Gazette on May 19.
The biosimilar references Stelara (ustekinumab), Johnson & Johnson’s IL‑12/23 inhibitor widely prescribed for immune‑mediated inflammatory diseases. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted marketing authorization in December 2025 for the treatment of plaque psoriasis and psoriatic arthritis. By blocking IL‑12 and IL‑23 signaling, ustekinumab reduces pathogenic immune activation that drives chronic skin and joint inflammation.
The launch represents a significant milestone for Samsung Bioepis’ expansion strategy in Japan, a market that continues to encourage biosimilar adoption to reduce healthcare costs while maintaining patient access to biologic therapies.
Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets at Samsung Bioepis, said the introduction of the ustekinumab biosimilar underscores the company’s commitment to broadening patient access to biologics for autoimmune diseases. The collaboration with NIPRO, established in June 2025, combines Samsung Bioepis’ biosimilar development expertise with NIPRO’s commercial infrastructure to advance multiple biosimilar candidates in Japan.
Samsung Bioepis already markets its ustekinumab biosimilar under different brand names across the European Union, South Korea, the United Kingdom, and the United States. The Japan launch expands the company’s global ustekinumab franchise as biosimilar competition accelerates across immunology markets.
The expansion also supports broader access to biologic therapies while strengthening Samsung Bioepis’ and NIPRO’s presence in Japan’s growing biosimilars sector.
Reference
Samsung Bioepis Launches Ustekinumab Biosimilar, Marking Its First Product Launch in Japan
