Samsung Bioepis has entered the U.S. market with its biosimilar version of the global immunotherapy drug Keytruda, which generates annual sales of approximately 46 trillion KRW (about 34.3 billion USD).
After initially applying for product approval in South Korea this August, the company has now begun the approval process in the U.S., ramping up its efforts to capture a share of the global market.
On October 30, Samsung Bioepis announced its submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SB27 (pembrolizumab), its biosimilar candidate for Keytruda.
Developed by Merck & Co. (known as MSD outside North America), Keytruda is an immunotherapy that recorded global sales of 31.7 billion USD last year, making it the world’s top-selling pharmaceutical product.
The drug works by binding to the PD-1 immune checkpoint receptor, enabling immune cells to recognize and attack cancer cells more effectively.
Samsung Bioepis is seeking U.S. approval for SB27 across 18 indications, including melanoma, non-small cell lung cancer, and head and neck cancer. The company aims to expand treatment options for patients by offering a more affordable alternative to Keytruda for various cancer types.
Beginning in 2024, Samsung Bioepis will conduct Phase 1 clinical trials involving 163 patients across four countries, and Phase 3 trials with 555 patients in 14 countries. These studies have demonstrated the biosimilar’s equivalence to the original drug, with both trials expected to conclude by year-end.
In August, Samsung Bioepis also filed for SB27 approval in South Korea, marking the country’s first application for a Keytruda biosimilar. By initiating the U.S. approval process, the company is positioning itself for global commercialization.
On October 26, Samsung Bioepis presented its Phase 1 clinical trial results for SB27 at the European Society for Medical Oncology (ESMO 2026) conference in Madrid, Spain.
The trial data showed pharmacokinetic equivalence to the original drug, with similar efficacy and safety profiles.
Dr. Shin Dong-hoon, Vice President and Head of Clinical Development at Samsung Bioepis, stated that it’s committed to demonstrating the research and development (R&D) expertise throughout the U.S. approval process for SB27. The goal is to increase treatment options and improve access for patients through biosimilars in the field of immuno-oncology.