INCHEON, Korea – February 21, 2024 – Samsung Bioepis Co., Ltd. today announced the initiation of Phase 1 clinical trial for SB27, the company's proposed biosimilar referencing Keytruda (pembrolizumab). The Phase 1 clinical trial for SB27 is a randomized, double-blind, three-arm, parallel group, multicenter study to compare the pharmacokinetics, efficacy, safety, and immunogenicity of pembrolizumab (SB27, EU-sourced Keytruda, and US-sourced Keytruda) in patients with stage II-IIIA non-small cell lung cancer following complete resection and adjuvant platinum-based chemotherapy. More information on this study is available at clinicaltrials.gov (NCT06268613).

As of February 2024, Samsung Bioepis has seven biosimilars approved and available around the worldⁱ –SB4 (etanercept), SB2 (infliximab), SB5 (adalimumab), SB3 (trastuzumab), SB8 (bevacizumab), SB11 (ranibizumab), and SB12 (eculizumab) – along with four other biosimilar candidates in pipeline – SB15 (aflibercept), SB16 (denosumab), and SB17 (ustekinumab) all of which have completed Phase 3 clinical trial and SB27 (pembrolizumab) in Phase 1 clinical trial.

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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. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X (Twitter), LinkedIn.