Samsung Bioepis applies for US FDA approval of Keytruda biosimilar

Samsung Bioepis has submitted a Biologics License Application to the US Food and Drug Administration (FDA) for SB27, a biosimilar candidate for the immunotherapy drug Keytruda. The application covers 18 indications, including melanoma, non-small cell lung cancer, and head and neck cancer.

SB27, which contains the active ingredient pembrolizumab, has undergone Phase 1 and Phase 3 clinical trials to demonstrate equivalence to the original drug. These trials involved 163 patients across four countries in Phase 1 and 555 patients across 14 countries in Phase 3. The company expects to complete all related clinical trials within this year.

Keytruda, developed by MSD, is a PD-1 immune checkpoint inhibitor that helps the immune system attack cancer cells. It recorded approximately $31.7 billion in global sales last year. While major substance patents for Keytruda in the US are set to expire in 2028, additional patents expiring in 2029 may influence the actual market entry timing for biosimilars.