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Denosumab biosimilar - Alvotech

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Drug Profile

Denosumab biosimilar - Alvotech

Alternative Names: Acvybra; AVT-03-Alvotech; AVT03; Kefdensis; Zvogra

Latest Information Update: 24 Sep 2025

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At a glance

  • Originator Alvotech
  • 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

  • Registered Bone disorders
  • Preregistration Corticosteroid-induced osteoporosis; Giant cell tumour of bone; Osteoporosis; Postmenopausal osteoporosis

Most Recent Events

  • 22 Sep 2025 Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for denosumab for corticosteroid-induced osteoporosis, osteoporosis, postmenopausal osteoporosis, giant cell tumour of bone, bone disorders
  • 19 Sep 2025 Registered for Bone disorders in Japan (SC)
  • 19 Sep 2025 Japanese Ministry of Health, Labor and Welfare recommends approval of AVT 03 for Rheumatoid arthritis in Japan

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