Samsung Biologics Epix announced on the 9th that it presented the results of a global Phase 3 clinical study of ‘SB27’ (generic name: pembrolizumab), its biosimilar candidate for Keytruda, at the 2026 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held in Phoenix, Arizona, USA, from the 4th to the 8th (local time).
At this conference, Samsung Biologics Epix showcased efficacy and safety data for SB27 in patients with metastatic non-squamous non-small cell lung cancer.
Keytruda, the original drug for which SB27 is a biosimilar, is an immunotherapy agent developed by US multinational pharmaceutical company MSD. It is a “blockbuster drug” that generated approximately 46 trillion won (31.7 billion dollars) in global revenue last year. With patent expiration approaching starting in 2028, competition among domestic and international pharmaceutical and biotechnology companies to develop biosimilars is fierce as they seek to secure market position.
Since 2024, Samsung Biologics Epix has conducted a randomized, double-blind Phase 3 clinical trial comparing SB27 with the original drug in 555 patients with metastatic non-squamous non-small cell lung cancer across 14 countries globally, administered in combination with standard chemotherapy.
Analysis of the clinical trial results confirmed that the primary endpoint of SB27, “Objective Response Rate (ORR) at Week 24,” met the pre-defined equivalence margin set by regulatory authorities, confirming clinical and medical equivalence with the original drug.
Additionally, similar results to the original drug were observed in key secondary efficacy endpoints, including △Progression-Free Survival (PFS), which is the period during which the cancer does not progress, △Duration of Response (DOR), which is the period during which the response state to the drug is maintained, and △Overall Survival (OS) of patients.
In terms of safety, the incidence rates of Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs after overall treatment were similar to those of the original drug. In particular, no neutralizing antibodies, which can neutralize the drug’s efficacy in the body, occurred even once.
Shin Dong-hoon, Vice President and Head of Clinical Medicine at Samsung Biologics Epix, stated, “Through this SITC presentation, we successfully demonstrated the primary endpoint in a large-scale global Phase 3 trial, proving the clinical and medical equivalence and consistent safety of SB27 compared to the original drug.” He added, “We will continue to focus our development capabilities to enhance patient access to high-quality oncology biologics and expand treatment benefits.”
Following its application for domestic marketing approval of SB27 to the Ministry of Food and Drug Safety in August—the first such application in Korea—Samsung Biologics Epix also applied for marketing approval in the US, the world’s largest market, earlier than major competitors last month. The company continues to maintain a leading position in the global competition to develop Keytruda biosimilars.
in THEBIO
