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Denosumab biosimilar - mAbxience

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Drug Profile

Denosumab biosimilar - mAbxience

Alternative Names: MB-09

Latest Information Update: 26 Jul 2024

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At a glance

  • Originator mAbxience
  • 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

Highest Development Phases

  • Phase III Osteoporosis

Most Recent Events

  • 22 May 2024 mAbxience completes a phase III trial in Osteoporosis in Bulgaria, Estonia, Georgia, Hungary, Latvia, Mexico, Poland, Serbia (SC) (NCT05338086) (EudraCT2021-003609-24)
  • 12 Oct 2023 Denosumab biosimilar licensed to Amneal Pharmaceuticals in the USA
  • 18 Mar 2023 mAbxience completes a phase I trial in Osteoporosis (In volunteers) in Poland (SC) (NCT05299073)

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