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

INCHEON, Korea I November 10, 2020 I 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 clinicaltrials.gov (#NCT04621318).

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 and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social mediaTwitterLinkedIn.

SOURCE: Samsung Bioepis

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