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Denosumab biosimilar - Gedeon Richter

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Drug Profile

Denosumab biosimilar - Gedeon Richter

Alternative Names: Xtrenbo; denosumab-qbde-Gedeon Richter; Enoby; Junod; RGB 14-P; RGB-14-X; Xtrenbo; Yaxwer

Latest Information Update: 23 Mar 2026

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At a glance

  • Originator Gedeon Richter
  • Developer Gedeon Richter; Hikma Pharmaceuticals
  • Class Antihypercalcaemics; Antineoplastics; Antirheumatics; Calcium regulators; Immunotherapies; Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; RANK ligand inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Registered Bone disorders; Bone metastases; Corticosteroid-induced osteoporosis; Giant cell tumour of bone; Male osteoporosis; Malignant hypercalcaemia; Osteoarthritis; Osteoporosis; Postmenopausal osteoporosis

Most Recent Events

  • 23 Mar 2026 Gedeon Richter initiates a phase I trial in healthy volunteers before October 2025
  • 17 Oct 2025 Adverse events, pharmacodynamics and pharmacokinetics data from a phase I trial in healthy volunteers presented at the 50th European Society for Medical Oncology Congress (ESMO-2025)
  • 26 Sep 2025 Registered for Bone disorders (Prevention) in USA (SC, Injection)

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