Samsung Bioepis Files for U.S. Approval of Keytruda Biosimilar

Global Phase 1 and 3 Trials Conducted to Compare SB27 with the Original Drug
U.S. Approval Application Follows South Korea Filing, Covering 18 Indications

Samsung Bioepis has filed for U.S. approval of SB27, a biosimilar candidate to the immuno-oncology drug Keytruda. SB27's active ingredient is pembrolizumab.

Samsung Bioepis said on Oct. 30 that it had submitted an application to the U.S. Food and Drug Administration (FDA) for approval of SB27. The application covers a total of 18 indications, including melanoma, non-small cell lung cancer, and head and neck cancer.

Samsung Epis Holdings logo image. Samsung Epis Holdings

Keytruda, the original drug, is an immuno-oncology drug developed by U.S. Merck (MSD). In 2025, it generated global sales of about $31.7 billion (approximately KRW 46 trillion), making it the world's best-selling drug. Keytruda works by binding to PD-1, an immune checkpoint protein, and suppressing cancer cells' ability to evade the immune system.

Since 2024, Samsung Bioepis has conducted global Phase 1 and Phase 3 clinical trials to assess the comparability of SB27 and the original drug. The Phase 1 trial involved 163 participants in four countries, while the Phase 3 trial involved 555 participants in 14 countries.

"We will once again demonstrate our research and development capabilities during the U.S. review of SB27's approval application, and work to expand patients' treatment options and improve access through biosimilars in the immuno-oncology field," said Shin Donghoon, vice president and head of Clinical Development at Samsung Bioepis.

Samsung Bioepis also filed for approval of SB27 in South Korea in August.

This content was produced with the assistance of AI translation services.