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 clinicaltrials.gov (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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MEDIA CONTACT
Anna Nayun Kim: nayun86.kim@samsung.com