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Samsung Bioepis Initiates Phase 3 Clinical Trial for SB16, Proposed Biosimilar to Prolia (Denosumab)

07:00 ON DEC 14, 2020 EST

INCHEON, Korea – December 14, 2020 – Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB16, the company's proposed biosimilar referencing Prolia (denosumab). The Phase 3 clinical trial for SB16 (denosumab) is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB16 compared to Prolia in 432 women with postmenopausal osteoporosis. More information on this study is available at (NCT04664959).

In October 2020, Phase 1 clinical trial for SB16 was initiated to compare the PK, PD, safety, tolerability, and immunogenicity between SB16 and Prolia in healthy volunteers.

As of December 2020, Samsung Bioepis has three biosimilar candidates – SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) – in Phase 3 clinical development.

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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: