Samsung Epis Holdings subsidiary Samsung Bioepis said on the 29th that SB27, a candidate biosimilar to the immuno-oncology drug "Keytruda (ingredient name pembrolizumab)," met its primary endpoints in global phase 1 and phase 3 trials, demonstrating equivalence to the originator.
Keytruda is an immuno-oncology drug developed by Merck (MSD) and is used to treat various cancers, including Non-small cell lung cancer (NSCLC), melanoma, and head and neck cancer. Its sales last year reached about 46 trillion won, making it the world's best-selling blockbuster drug.
Amid intensifying competition among global pharmaceutical and biotech corporations to secure the Keytruda biosimilar market, Samsung Bioepis is the first to disclose global phase 3 results, the company said.
Since 2024, Samsung Bioepis has conducted global phase 1 and phase 3 trials comparing the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 and the originator in patients with Non-small cell lung cancer (NSCLC).
Phase 1 was conducted with 163 patients across four countries, including Korea. For the primary endpoint pharmacokinetic analysis, the area under the concentration-time curve (AUC), which reflects systemic drug exposure, was measured, and the pre-specified criteria were met, confirming pharmacokinetic equivalence with the originator.
In phase 3, which enrolled 555 patients across 14 countries, the primary endpoint was the objective response rate (ORR), defined as the proportion of patients whose tumors shrank by a certain threshold after 24 weeks of treatment. SB27 was shown to be equivalent to the originator in terms of efficacy. Safety and immunogenicity were also similar.
Since last year, Samsung Bioepis has applied an "overlap" strategy, conducting phases 1 and 3 simultaneously to accelerate SB27 development, and plans to complete both trials within the year.
Shin Dong-hoon, head of clinical medicine at Samsung Bioepis (executive vice president), said, "SB27 demonstrating equivalence to the originator is a meaningful achievement that showcases Samsung Bioepis' global biosimilar development capabilities," adding, "Based on a rigorous quality control system, we will work to improve patients' access to treatment in the immuno-oncology field as well."