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Denosumab biosimilar - Luye Pharma

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Drug Profile

Denosumab biosimilar - Luye Pharma

Alternative Names: Anti-RANKL monoclonal antibody; BA-1102; BA-6101; Boluojia; Boyoubei; LY-01011; LY-06006

Latest Information Update: 13 Jun 2024

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At a glance

  • Originator Shandong Boan Biotechnology
  • Developer Luye Pharma Group; Parexel International; Shandong Boan Biotechnology
  • 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

  • Marketed Osteoporosis
  • Registered Giant cell tumour of bone
  • Preregistration Bone metastases; Multiple myeloma
  • Phase III Postmenopausal osteoporosis
  • No development reported Unspecified

Most Recent Events

  • 27 May 2024 Registered for Giant cell tumour of bone (Inoperable/Unresectable, In adults, In adolescents) in China (SC)
  • 27 May 2024 Shandong Boan Biotechnology plans to launch Denosumab biosimilar for Bone metastases and multiple myeloma in other countries
  • 27 May 2024 Shandong Boan Biotechnology plans to file BLA application for denosumab biosimilar in the US, European Union and Japan

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