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…
Samsung Bioepis announced at the Society for Immunotherapy of Cancer Annual Meeting 2026 that its proposed biosimilar SB27 demonstrated comparable efficacy and safety to Keytruda in a global Phase 3 clinical trial. Keytruda, a blockbuster cancer immunotherapy drug developed by MSD, generates approximately 46 trillion won ($31.7 billion) in global sales annually.
The Phase 3 study, which began in 2024 and involved 555 patients with metastatic nonsquamous non-small cell lung cancer across 14 countries, compared SB27 with Keytruda in combination with standard chemotherapy. SB27 met its primary endpoint by demonstrating an equivalent objective response rate to the original drug.
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