[Edaily Reporter Hong Ju-yeon ] Samsung Bioepis has become the first company to announce the results of its global Phase 3 clinical trial for a Keytruda biosimilar. This achievement comes amid fierce competition in the development of Keytruda biosimilars.

Samsung Bioepis announced on the 29th that it has demonstrated equivalence to the originator drug in global Phase 1 and Phase 3 clinical trials of its Keytruda biosimilar (active ingredient: pembrolizumab; project name: SB27).

Keytruda, the originator drug for SB27, is an immuno-oncology drug developed by the multinational pharmaceutical company MSD. It is used to treat various types of cancer, including non-small cell lung cancer, melanoma, and head and neck cancer, and is the world’s top-selling blockbuster drug, having recorded sales of approximately 46 trillion won ($31.7 billion) last year.

Starting in 2024, Samsung Bioepis conducted global Phase 1 and Phase 3 clinical trials comparing the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 with the originator drug in patients with non-small cell lung cancer. In the Phase 1 clinical trial involving 163 participants across four countries, including South Korea, measurements of the primary endpoint—the “area under the concentration-time curve (AUC)”—met the pre-established criteria, confirming pharmacokinetic equivalence with the originator drug.

In the Phase 3 clinical trial, which enrolled 555 patients across 14 countries, the “objective response rate (ORR)”—the percentage of patients whose tumor size decreased by a certain threshold or more after 24 weeks of treatment—was analyzed as the primary endpoint. The results showed that SB27 demonstrated equivalence in efficacy compared to the reference product. Similar results to the reference product were also observed in other areas, including safety and immunogenicity.

Shin Dong-hoon, Executive Vice President and Head of the Clinical Medicine Division at Samsung Bioepis, stated, “Demonstrating the equivalence of SB27 to the originator drug is a significant achievement that highlights our global biosimilar development capabilities.” He added, “Based on our rigorous quality management system, we will continue our efforts to improve patient access to treatment through biosimilars in the field of immuno-oncology as well.”

Samsung Bioepis is accelerating its development schedule through an “overlap” strategy, in which Phase 1 and Phase 3 clinical trials will commence simultaneously in 2024. Both clinical trials are scheduled to be completed within the year.