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 on Monday that its biosimilar SB27 has demonstrated equivalent efficacy and safety to Keytruda, a leading cancer immunotherapy drug, in a global Phase 3 clinical trial. The company announced the results of the study at the Society for Immunotherapy of Cancer Annual Meeting 2026 in Phoenix, Arizona, from November 4 to 8.
Keytruda, manufactured by U.S. pharmaceutical company MSD, works by targeting the programmed cell death protein 1 (PD-1), a receptor that plays a role in immune checkpoint regulation, enabling the immune system to target cancer cells. It became the world's best-selling drug in 2023, generating around 46 trillion won ($31.7 billion) in global sales.
The Phase 3 trial, which started in 2024, included 555 patients with metastatic nonsquamous non-small cell lung cancer from 14 countries. They compared SB27 with Keytruda in combination with standard chemotherapy. The results showed that SB27 met its primary endpoint by achieving an equivalent objective response rate to Keytruda.
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