Samsung Bioepis said Friday that it has applied to the U.S. Food and Drug Administration (FDA) for marketing authorization of 'SB27' (active ingredient: pembrolizumab), a biosimilar (replica biologic) of Keytruda.
Keytruda, the original drug for SB27, is an immunotherapy agent developed by global pharmaceutical company MSD (Merck in the U.S.) and is a blockbuster drug with global sales of approximately 46 trillion won ($31.7 billion) last year.
It works by binding to the immune checkpoint receptor PD-1 (Programmed cell Death Protein-1), thereby inhibiting cancer cells' evasion of the immune system and helping the human immune system attack cancer cells. It holds broad indications across various cancer types, and the indications targeted in this SB27 marketing authorization application include a total of 18 diseases, such as melanoma, non-small cell lung cancer, and head and neck cancer.
Samsung Bioepis accelerated its development schedule by employing an 'overlap strategy' that concurrently conducted Phase 1 clinical trials involving 163 patients in four countries globally and Phase 3 clinical trials involving 555 patients in 14 countries globally, starting from 2024.
Through this, the company confirmed equivalence with the original drug and obtained results showing that, in terms of safety, the rates of treatment-emergent adverse events (TEAE) and serious treatment-emergent adverse events (Serious TEAE) after overall treatment were similar to those of the original drug.
In South Korea, the company is taking a first-mover approach by applying for SB27 marketing authorization in August last with indications covering a total of 16 diseases, including melanoma, non-small cell lung cancer, and head and neck cancer, making it the earliest Keytruda biosimilar application.
In the U.S., German company Fomicon and Indian company Zydus Lifesciences jointly announced in mid-this month that their marketing authorization application for the Keytruda biosimilar 'FYB206' had been accepted for FDA review.
Shin Dong-hoon, head of Clinical Medicine at Samsung Bioepis, said, "We will strive to once again demonstrate our research and development capabilities during the U.S. marketing authorization review process for SB27, and to expand treatment options and improve accessibility for patients through biosimilars in the immunotherapy field."
in THEBIO
