Denosumab biosimilar - Gedeon Richter
Alternative Names: Junod; RGB 14-P; YaxwerLatest Information Update: 12 May 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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)