Samsung Bioepis has confirmed pharmacokinetic equivalence between its biosimilar candidate and the original drug as it advances development of a biosimilar to Keytruda, a blockbuster immunotherapy used to treat cancer.
Samsung Bioepis announced on the 27th that it presented Phase 1 clinical trial results for SB27, its biosimilar candidate containing pembrolizumab, at the European Society for Medical Oncology Congress 2026, held in Madrid, Spain, from the 23rd to the 27th.
Keytruda, the reference drug for SB27, is an immunotherapy developed by U.S. pharmaceutical company MSD. It works by binding to the immune checkpoint receptor PD-1, helping prevent cancer cells from evading the immune system. The drug is used to treat various types of cancer.
Keytruda generated approximately $31.7 billion in global sales last year, making it the world’s top-selling drug.
Samsung Bioepis has conducted a Phase 1 trial of SB27 since 2024 in 163 patients with non-small cell lung cancer across four countries, including South Korea. The trial compared the pharmacokinetic profiles of patients receiving SB27 with those receiving the original Keytruda approved in the United States and Europe.
Analysis of the area under the blood concentration-time curve (AUC), the primary endpoint, demonstrated pharmacokinetic equivalence between SB27 and the reference drug. Assessments of efficacy and safety also showed similar results for the two drugs, supporting the candidate’s potential as a biosimilar.
Samsung Bioepis had previously confirmed equivalence to the reference drug in a global Phase 3 trial. Among 555 patients with non-small cell lung cancer across 14 countries, the study assessed the objective response rate (ORR) at Week 24 and met the prespecified criteria for efficacy equivalence.
In August, Samsung Bioepis applied to South Korea’s Ministry of Food and Drug Safety for marketing approval of SB27. The application covers 16 indications, including melanoma, non-small cell lung cancer and head and neck cancer.
Samsung Bioepis plans to continue developing SB27 based on the latest clinical findings. The company also intends to focus on research and development to expand its biosimilar portfolio in the global immuno-oncology market.
Shin Dong-hoon, vice president and head of clinical and medical affairs at Samsung Bioepis, said, “The Phase 1 results for SB27 confirmed pharmacokinetic equivalence to the reference drug, along with similar efficacy and safety. We will continue developing cancer biosimilars that patients and healthcare professionals can trust, guided by rigorous analytical and clinical standards.”