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A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab with Prolia in Postmenopausal Women with Osteoporosis (LUMIADE-3 Study)

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Trial Profile

A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab with Prolia in Postmenopausal Women with Osteoporosis (LUMIADE-3 Study)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2025

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms LUMIADE-3
  • Sponsors Fresenius Kabi

Most Recent Events

  • 28 Mar 2025 According to a Fresenius Kabi media release, he Biologics License Application (BLA) for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) has been approved by the U.S. Food and Drug Administration (FDA).
  • 11 Jul 2024 According to a Fresenius Kabi media release, the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications (MAAs) for its biosimilar candidates of Prolia (denosumab) and Xgeva (denosumab), The MAA submissions are based two comparative clinical studies (i.e., comparative PK, PD and immunogenicity study conducted in healthy volunteers and a comparative efficacy, PD, safety, and immunogenicity study conducted in women with PMO).
  • 04 Jun 2024 Results assessing the safety and efficacy of FKS518 compared to the originator in postmenopausal women with osteoporosiswere presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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