Samsung Bioepis Announces Positive Preliminary Phase 1 and Phase 3 Data for SB27, a Proposed Biosimilar to Keytruda (Pembrolizumab)

Samsung Bioepis Announces Positive Preliminary Phase 1 and Phase 3 Data for SB27, a Proposed Biosimilar to Keytruda (Pembrolizumab)

Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda; Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24

Phase 1 and Phase 3 studies expected to be completed within 2026

Samsung Bioepis Co., Ltd. announced today that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), have met their primary endpoints.

“We are excited to announce preliminary results from the Phase 1 and Phase 3 studies for SB27, our pembrolizumab biosimilar candidate. These topline positive results reinforce our scientific expertise and leadership in biosimilar development,” said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis. “We are on track to complete both Phase 1 and Phase 3 studies within this year. Leveraging our robust quality management system, we remain committed to advancing our biosimilar portfolio to broaden access to life-saving biologic medicines for patients with unmet needs.”