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Denosumab biosimilar - GlycoNex

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Drug Profile

Denosumab biosimilar - GlycoNex

Alternative Names: SPD Denosumab biosimilar - GlycoNex; SPD-8

Latest Information Update: 14 Jan 2025

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At a glance

  • Originator GlycoNex; Mitsubishi Gas Chemical - Nisshin Pharma (JV)
  • Developer GlycoNex
  • 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
  • Preclinical Cancer

Most Recent Events

  • 14 Jan 2025 GlycoNex announces expects regulatory approval and commercialization by 2027
  • 08 Jan 2025 Phase-III clinical trials in Osteoporosis (Parenteral)
  • 06 Jan 2025 Denosumab biosimilar licensed to unknown company

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