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Denosumab biosimilar - Samsung Bioepis

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Drug Profile

Denosumab biosimilar - Samsung Bioepis

Alternative Names: SB-16

Latest Information Update: 31 May 2024

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At a glance

  • Originator Samsung Bioepis
  • 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 Postmenopausal osteoporosis
  • Phase I Osteoporosis

Most Recent Events

  • 27 May 2024 eEfficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity data from phase-III trial in Osteoporosis released by Samsung Bioepis
  • 10 Nov 2023 Safety and efficacy data from a phase III trial in Postmenopausal osteoporosis presented at the American College of Rheumatology Convergence (ACR-ARP-2023)
  • 15 Oct 2023 Efficacy data from a phase III trial in Postmenopausal osteoporosis released by Samsung Bioepis

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