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

INCHEON, Korea--(BUSINESS WIRE)--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.”

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).²

The randomized, double-blind, three-arm, parallel group, multicenter Phase 1 clinical trial demonstrated pharmacokinetic (PK) bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. The study assessed PK, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA NSCLC following complete resection and adjuvant platinum-based chemotherapy.³ 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every 3 weeks up to 51 weeks, and blood samples were collected. The preliminary PK evaluation indicates that the drug exposure, measured by the Area Under the Curve (AUC), has met the predefined equivalence criteria.

The randomized, double-blind, parallel group, multicenter Phase 3 clinical trial demonstrated equivalent objective response rate (ORR) at Week 24. The study assessed efficacy, safety, PK, and immunogenicity of SB27 and Keytruda in patients with metastatic non-squamous NSCLC, followed by chemotherapy.⁴ 555 participants were randomized to receive SB27 or Keytruda followed by pemetrexed and carboplatin⁵ every 3 weeks up to 48 weeks. The 90% confidence interval (CI) for the ORR ratio between SB27 and Keytruda at Week 24 was 0.737 to 1.071, which completely fell within the pre-defined equivalence margin of 0.712 to 1.405, thereby demonstrating equivalence. Safety, PK and immunogenicity profiles of SB27 were also comparable with those of Keytruda.

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 and neurology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

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

^2 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 June 2026.

^3 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 June 2026)

^4 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 June 2026)

^5 Carboplatin was administered for the first four cycles.