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A Randomized, Double-Blind, Multicenter, Parallel-Arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia in Postmenopausal Women With Osteoporosis

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Trial Profile

A Randomized, Double-Blind, Multicenter, Parallel-Arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia in Postmenopausal Women With Osteoporosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 May 2025

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms DEVOTE
  • Sponsors Biocon Biologic

Most Recent Events

  • 28 Apr 2025 According to Biocon Biologics media release, announced that the CHMP has issued positive opinions recommending the authorization of its denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo and Denosumab BBL. The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited and these recommendations follow a review of comprehensive data packages, including clinical results from this study.
  • 24 Jul 2024 Status changed from active, no longer recruiting to completed.
  • 08 May 2023 Status changed from recruiting to active, no longer recruiting.

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