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

• Phase 1 study has demonstrated pharmacokinetics (PK) equivalence between SB27 and Keytruda
• Phase 1 and Phase 3 studies expected to be completed within 2026 

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. announced today that the Phase 1 study on SB27, a proposed biosimilar to Keytruda¹ (pembrolizumab), has met its primary pharmacokinetics (PK) endpoints. The randomized, double-blind, three-arm, parallel group, multicenter clinical trial demonstrated pharmacokinetic bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda.

Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.² The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every 3 weeks, maximum 18 cycles over about 51 weeks, and blood samples were collected. The preliminary pharmacokinetic evaluation indicates that the drug exposure, measured by the Area Under the Curve (AUC), has met the predefined equivalence criteria.

“We are excited to announce preliminary results from the Phase 1 study 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, 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 for patients with unmet needs.”

The Phase 3 study, initiated in March 2024, is expected to be completed within 2026.³ The objective of the study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda in patients with metastatic non-squamous non-small cell lung cancer.

Pembrolizumab is a humanized monoclonal antibody that acts as an immune checkpoint inhibitor by targeting and blocking the programmed cell death protein 1 (PD-1) receptor on T cells. It is used to treat various types of cancer, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell cancer (HNSCC).⁴

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

¹ Keytruda is a registered trademark of Merck Sharp & Dohme LLC

² ClinicalTrials.gov (NCT06268613). A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy. Available at: https://clinicaltrials.gov/study/NCT06268613 (Accessed May 2026)

³ ClinicalTrials.gov (NCT06348199). A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer. Available at: https://clinicaltrials.gov/study/NCT06348199 (Accessed May 2026)

⁴ European Medicines Agency (EMA). Keytruda Summary of Product Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf Last accessed April 2026.