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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: 06 Jan 2026

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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

  • 01 Dec 2025 According to a Fresenius Kabi media release, denosumab biosimilars Conexxence and Bomyntra received approval from the European Commission in July 2025 for all indications of the reference products Prolia and Xgeva respectively.
  • 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).

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