News | November 10, 2020

Samsung Bioepis Initiates Phase 1 Clinical Trial For SB16, Proposed Biosimilar To Prolia (Denosumab)

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, visit (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, visit

Source: Samsung Bioepis Co., Ltd.