Samsung Bioepis demonstrates pharmacokinetic equivalence for Keytruda biosimilar

Samsung Bioepis announced the results of its Phase 1 clinical trial for SB27, a biosimilar candidate for the immunotherapy drug Keytruda (pembrolizumab), at the European Society for Medical Oncology (ESMO) 2026 annual meeting in Madrid, Spain.

The study, conducted since 2024 with 163 non-small cell lung cancer patients across four countries including South Korea, demonstrated pharmacokinetic equivalence to the original drug. The primary endpoint, the area under the curve (AUC) of blood concentration-time, showed equivalence, while efficacy and safety profiles were also found to be similar to the original medication.

Keytruda, developed by MSD, is a leading PD-1 inhibitor with global annual sales reaching approximately 46 trillion KRW (31.7 billion USD). As major patents for Keytruda approach expiration in 2028, Samsung Bioepis aims to accelerate the commercialization of SB27 to expand its oncology portfolio.