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Samsung Bioepis Initiates Phase 1 Clinical Trial for SB17, Proposed Biosimilar to Stelara (Ustekinumab)

07:00 ON MAR 01, 2021 EST

INCHEON, Korea – March 01, 2021 – Samsung Bioepis Co., Ltd. today announced the initiation of Phase 1 clinical trial for SB17, the company's proposed biosimilar referencing Stelara (ustekinumab). The Phase 1 clinical trial for SB17 (ustekinumab) is a randomized, double-blind, three-arm, parallel, single-dose study to compare the pharmacokinetics (PK), safety, tolerability, and immunogenicity of Stelara and SB17 in healthy male volunteers. More information on this study is available at (NCT#04772274).

As of March 2021, Samsung Bioepis has four biosimilar candidates in clinical development –  SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in Phase 3 clinical trial and SB17 (ustekinumab) in Phase 1 clinical trial.

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

Anna Nayun Kim: