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              Samsung Bioepis

              • Development Update

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              KOREA, REPUBLIC OF Korea, Republic Of

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

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              Lead Product(s): Denosumab

              Therapeutic Area: Musculoskeletal Product Name: SB16

              Highest Development Status: Phase I Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 10, 2020

              Details:

              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.

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