Samsung Bioepis Confirms SB27 Equivalence to Keytruda
The biosimilar candidate met primary pharmacokinetic endpoints in a Phase 1 clinical trial.
Updated on Oct. 27, 2026 in Biotech
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Samsung Bioepis reported that its biosimilar SB27 achieved pharmacokinetic equivalence to the reference drug Keytruda in Phase 1 clinical trials. Trial results demonstrated that SB27 mirrors the original drug in safety and efficacy profiles.
Why it matters
The successful trial represents a significant step in the development of a biosimilar for one of the worlds top-selling pharmaceutical products. Introducing competition for established biologics can increase market access and provide more options for patient care.
The clinical trial of 163 participants with non-small cell lung cancer measured pharmacokinetic equivalence through blood concentration analysis. Patients received either SB27 or the approved drug, with researchers determining efficacy by comparing the area under the curve.
The players
Samsung Bioepis
This is a biopharmaceutical company that specializes in the development and manufacture of biosimilar medicines.
MSD
Known as Merck in the United States and Canada, this is a multinational pharmaceutical company that manufactures Keytruda.
European Society for Medical Oncology
This is a leading professional organization for medical oncology that hosts major scientific conferences for researchers.
The details
Samsung Bioepis presented these findings at the European Society for Medical Oncology conference in Madrid. The trial was conducted across four countries, including South Korea, to validate the biosimilar candidate.
Timeline
Samsung Bioepis began Phase 1 clinical trials in 2024.
Keytruda recorded global sales of approximately 31.7 billion dollars in 2025.
Trial results were presented at ESMO in Madrid between October 23 and 27, 2026.
The Tech Race
The presentation of SB27 data at the European Society for Medical Oncology follows a long-standing industry pattern of unveiling clinical results at major global oncology summits. This move highlights the competitive push by developers to challenge high-revenue biologics with cost-effective biosimilar alternatives.
The potential future introduction of a biosimilar could increase availability and competition within the medical market for cancer treatments. For patients, this often translates to broader access to therapy options as pharmaceutical alternatives enter the supply chain.
The takeaway
Developing biosimilars for high-revenue drugs is a critical strategy for expanding therapeutic access on a global scale. As these candidates move through clinical phases, they provide a roadmap for how medical innovation can evolve to lower costs for major treatment protocols.
What happens next
Samsung Bioepis is scheduled to continue the clinical development of SB27, though no specific dates for subsequent trial phases have been announced.
Further reading
Learn more about the latest industry developments in the Biotech section.
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