Samsung Bioepis Demonstrates Equivalence to Keytruda in Phase 1 Trial of 'SB27'

Presented at ESMO 2026
Efficacy and safety similar to the original drug

Samsung Bioepis has demonstrated pharmacokinetic equivalence to the original drug in a Phase 1 clinical trial of SB27 (generic name: pembrolizumab), its biosimilar candidate for Keytruda, the world's top-selling immuno-oncology drug. Its efficacy and safety were also found to be similar to those of the original drug.

A Samsung Bioepis official presents a poster on the Phase 1 results for its Keytruda biosimilar SB27 at the European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, on the 26th. Samsung Bioepis

On the 27th, Samsung Bioepis said it had presented the Phase 1 results for SB27 in a poster at the European Society for Medical Oncology (ESMO 2026) Congress, held in Madrid, Spain, on the 26th.

An analysis of the primary endpoint, the area under the curve (AUC) of blood concentration over time up to a specified point after drug administration, confirmed that SB27 was pharmacokinetically equivalent to the original drug. This means the drug is absorbed and remains in the body to a similar extent as the original.

The clinical trial has been conducted since 2024 in four countries, including South Korea, involving 163 patients with non-small cell lung cancer. The patients were divided into two groups: one received SB27, while the other received Keytruda approved in the United States and Europe.

Keytruda, an immuno-oncology drug developed by U.S.-based MSD, recorded global sales of approximately $31.7 billion (about KRW 46 trillion) last year. It binds to PD-1, an immune checkpoint receptor, preventing cancer cells from evading the immune system and helping the body's immune cells attack them. Thanks to this mechanism of action, the drug has broad indications across various cancer types.

"The Phase 1 results confirmed pharmacokinetic equivalence to the original drug, as well as similar efficacy and safety," said Shin Dong-hoon, head of Clinical Development at Samsung Bioepis. "We will continue developing anticancer biosimilars that patients and healthcare professionals can trust, guided by high analytical and clinical standards."

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