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Samsung Bioepis Initiates Phase 1 Clinical Trial for SB16, Proposed Biosimilar to Prolia® (Denosumab)

INCHEON, Korea – November 10, 2020 – Samsung Bioepis Co., Ltd. today announced the initiation of Phase 1 clinical trial for SB16, the company's proposed biosimilar referencing Prolia® (denosumab). The Phase 1 clinical trial for SB16 (denosumab) is a randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity between SB16 and Prolia® in healthy male volunteers. For more information, please visit (NCT04621318).

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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 and gastroenterology. For more information, please visit: and follow us on social media– Twitter, LinkedIn.

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