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Denosumab biosimilar - GlycoNex

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Drug Profile

Denosumab biosimilar - GlycoNex

Alternative Names: SPD Denosumab biosimilar - GlycoNex; SPD-8; SPD8-P; SPD8-R

Latest Information Update: 16 Jun 2026

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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
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Osteoporosis
  • Preclinical Cancer

Most Recent Events

  • 10 Jun 2026 Denosumab biosimilar - GlycoNex is available for licensing in World as of 10 Jun 2026. www.glyconex.com
  • 29 Oct 2025 GlycoNex plans regulatory submission for Osteoporosis
  • 14 Jan 2025 GlycoNex announces expects regulatory approval and commercialization by 2027

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