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Denosumab biosimilar - Gedeon Richter

Drug Profile

Denosumab biosimilar - Gedeon Richter

Alternative Names: Junod; RGB 14-P; Yaxwer

Latest Information Update: 12 May 2025

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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

  • Preregistration Bone disorders; Bone metastases; Giant cell tumour of bone; Postmenopausal osteoporosis

Most Recent Events

  • 25 Apr 2025 CHMP of EMA recommends approval of Denosumab biosimilar for bone diseases and osteoporosis in European Union
  • 24 Apr 2025 Committee for Medicinal Products for Human Use (CHMP) recommends approval of Denosumab biosimilar for Postmenopausal osteoporosis, Giant cell tumour of bone and Bone metastasis in European Union
  • 12 Dec 2024 Preregistration for Bone metastases in USA (SC)

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