Samsung Bioepis said its biosimilar candidate for Keytruda, the global blockbuster immuno-oncology drug with annual sales of 46 trillion won, showed equivalence to the original treatment in a Phase 1 trial.
The company said on the 27th that it presented the Phase 1 results for SB27, its Keytruda biosimilar candidate, at the European Society for Medical Oncology congress (ESMO 2026) held in Madrid, Spain, from the 23rd to the 27th. The findings were released in a poster session on the 26th.
Keytruda, developed by U.S. drugmaker MSD, is the world's top-selling medicine, with global sales of about $31.7 billion (46 trillion won) last year. It binds to PD-1, an immune checkpoint receptor, to block cancer cells from evading the immune system, and is used to treat a range of cancers.
Samsung Bioepis has run the Phase 1 trial of SB27 since 2024 in four countries including South Korea, enrolling 163 patients with non-small cell lung cancer. Patients were divided into groups receiving either SB27 or Keytruda approved in the United States and Europe, and the two were compared on pharmacokinetics, efficacy and safety.
The trial confirmed pharmacokinetic equivalence between SB27 and the original drug in the primary endpoint, an analysis of the area under the blood concentration-time curve (AUC). Efficacy and safety were also comparable.
"In the Phase 1 trial of SB27, we confirmed pharmacokinetic equivalence with the original drug and similarity in efficacy and safety," said Shin Dong-hoon, executive vice president and head of the clinical development division at Samsung Bioepis. "Based on high analytical and clinical standards, we will continue developing oncology biosimilars that patients and medical professionals can trust."