Samsung Bioepis has demonstrated the equivalence of its biosimilar to the immuno-oncology drug Keytruda (active ingredient: pembrolizumab; project name: SB27) in global clinical trials.
On June 30, Samsung Bioepis announced positive results from the global clinical trials for SB27, confirming equivalence with the original drug Keytruda in both Phase 1 and Phase 3 primary endpoints.
Keytruda, developed by the multinational pharmaceutical company Merck (MSD), is a blockbuster immuno-oncology drug that generated approximately 46 trillion won ($31.7 billion) in global sales last year. The substance patent for Keytruda will expire sequentially starting in 2028 in South Korea, followed by 2029 in the United States and 2031 in Europe.
Samsung Bioepis accelerated the development of SB27 by implementing an 'overlap' strategy, conducting both Phase 1 and Phase 3 trials simultaneously in 2024.
The Phase 1 trial involved 163 patients with non-small cell lung cancer across four countries, and it met the equivalence criteria based on the area under the concentration-time curve (AUC).
The Phase 3 trial included 555 patients from 14 countries. The analysis of the objective response rate (ORR) at week 24 showed that the efficacy was equivalent to that of the original drug.
Based on these results, Samsung Bioepis plans to continue the development of SB27, aiming to complete clinical trials within the year.
Shin Dong-hoon, Vice President and Head of Clinical Development at Samsung Bioepis, stated, "We aim to enhance patient access to treatment through biosimilars in the field of immuno-oncology."
* This article has been translated by AI.
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