Samsung Bioepis' Keytruda biosimilar demonstrates equivalence in global Phase 3 trial

Samsung Bioepis said Monday that its proposed biosimilar SB27 demonstrated comparable efficacy and safety to Keytruda, a blockbuster cancer immunotherapy drug that was the world's best-selling pharmaceutical product last year, in a global Phase 3 clinical trial. According to the company, it announced the Phase 3 clinical study results at the Society for Immunotherapy of Cancer Annual Meeting 2026 held in Phoenix, Arizona from Nov. 4 to 8. Keytruda, developed by U.S. pharmaceutical company MSD, is a cancer immunotherapy drug that binds to programmed cell death protein 1 (PD-1), an immune checkpoint receptor, helping the immune system attack cancer cells. It was the world's best-selling drug last year, generating approximately 46 trillion won ($31.7 billion) in global sales. The Phase 3 study, which began in 2024, involved 555 patients with metastatic nonsquamous non-small cell lung cancer across 14 countries, comparing SB27 with the original drug in combination with standard chemotherapy. In the study, SB27 met its primary endpoint by demonstrating an equivalent objective response rate to