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Denosumab biosimilar - Fresenius Kabi

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Drug Profile

Denosumab biosimilar - Fresenius Kabi

Alternative Names: FKS-518

Latest Information Update: 15 Jul 2024

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At a glance

  • Originator Fresenius Kabi
  • Class Antihypercalcaemics; Antineoplastics; Antirheumatics; Calcium regulators; Immunotherapies; Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action 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

Highest Development Phases

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

Most Recent Events

  • 11 Jul 2024 Preregistration for Bone disorders in European Union (SC)
  • 11 Jul 2024 Preregistration for Giant cell tumour of bone in European Union (SC)
  • 11 Jul 2024 Preregistration for Osteoporosis in European Union (SC)

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