Samsung Bioepis announced on Aug. 10 that it has submitted a marketing authorization application to South Korea's Ministry of Food and Drug Safety for SB27 (ingredient name: pembrolizumab), its biosimilar candidate referencing the blockbuster cancer therapy Keytruda.
Keytruda, an immuno-oncology drug developed by U.S. pharmaceutical company MSD, is the world’s top-selling medicine, generating approximately 46 trillion won ($31.7 billion) in global sales last year.
Keytruda functions by binding to programmed cell death protein 1 (PD-1), an immune checkpoint receptor on T cells that acts as a brake on the immune system. Cancer cells often evade destruction by activating PD-1 through proteins like PD-L1. Keytruda blocks PD-1, releasing the brakes and enabling T cells to target and attack cancer cells.
First to Enter Korean Market Review for Pembrolizumab
Because of its mechanism, Keytruda covers a broad spectrum of oncology indications. Samsung Bioepis’s approval filing encompasses 16 indications, including melanoma, non-small cell lung cancer, and head and neck cancer.
Amid intensifying global competition to develop Keytruda biosimilars, this filing makes Samsung Bioepis the first company to enter the official marketing approval process for a Keytruda biosimilar in South Korea. Keytruda’s primary compound patent in South Korea is slated to expire in 2028.
Clinical Equivalence Confirmed via Global Phase 3 Trial
Samsung Bioepis demonstrated clinical equivalence to the originator drug through a Phase 1 clinical trial involving 163 patients across four countries starting in 2024, as well as a Phase 3 trial involving 555 patients across 14 countries.
“Through this regulatory review process, we will thoroughly present the research and development achievements of SB27 and navigate the approval procedures smoothly,” said Shin Dong-hoon, vice president and head of Clinical Development at Samsung Bioepis. “We remain committed to delivering new immuno-oncology treatment options to patients in South Korea as quickly as possible.”
