Samsung Bioepis has begun the domestic approval process for a biosimilar to Keytruda, the world's top-selling medicine. This is the first time an application for approval of a Keytruda biosimilar has been filed in Korea.
Samsung Bioepis said on the 10th it applied to the Ministery of Food and Drug Safety for marketing approval of its Keytruda biosimilar candidate SB27 (ingredient name pembrolizumab).
Keytruda, the original medicine, is an immuno-oncology drug developed by U.S. company MSD. It posted about $31.7 billion (about 46 trillion won) in global sales last year, ranking No. 1 among prescription drugs worldwide.
It works by blocking the action of the PD-1 protein, which helps cancer cells evade attacks by the immune system, thereby enabling immune cells to attack cancer cells, and it has secured indications across various tumor types.
This application includes indications for a total of 16 diseases, including melanoma, Non-small cell lung cancer (NSCLC), and head and neck cancer.
Samsung Bioepis has conducted global trials of SB27 since 2024. Phase 1 involved 163 participants in four countries, and phase 3 involved 555 participants in 14 countries; the company said it confirmed equivalence with the original medicine.
With this application, competition to develop a Keytruda biosimilar in Korea is expected to intensify. Samsung Bioepis plans to explain its clinical and research and development results during the Ministery of Food and Drug Safety review process and proceed with approval to offer domestic patients a new immuno-oncology treatment option.
Samsung Bioepis currently sells 11 biosimilars in Korea, including treatments for autoimmune diseases, oncology, ophthalmology, and rare diseases. It is also developing seven follow-on biosimilar pipeline products, including SB27.