Samsung Bioepis wins Japan approval for Stelara biosimilar under Nipro partnership

South Korean biotech Samsung Bioepis has secured Japanese marketing approval for its ustekinumab biosimilar, referencing Stelara (ustekinumab). The product will be commercialized by Japanese medical products group Nipro (TYO: 8086), marking the first approval under the companies’ partnership signed in June.

The biosimilar is approved for plaque psoriasis and psoriatic arthritis. It is due to be listed on Japan’s National Health Insurance drug price list in May 2026, enabling a launch immediately after reimbursement, a critical step in the tightly regulated Japanese market.

Samsung Bioepis said the approval supports wider access to lower-cost biologics in Japan, where healthcare spending pressures are mounting. While biosimilar uptake has historically lagged Western markets, policy reforms and pricing incentives are gradually shifting prescribing behavior.