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A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia in Postmenopausal Women With Osteoporosis

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Trial Profile

A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia in Postmenopausal Women With Osteoporosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2025

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis

    • Most Recent Events

    • 15 Nov 2024 According to the Samsung BioLogics Media Release, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two denosumab biosimilars based on clinical data from this study.
    • 15 Jun 2024 Results comparing SB16 to reference denosumab in patients with postmenopausal osteoporosis , presented at the 25th Annual Congress of the European League Against Rheumatism
    • 27 May 2024 According to Samsung Bioepis media release, data from this trial presented at the European Calcified Tissue Society (ECTS) Congress 2024.

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