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Nivolumab biosimilar - Xbrane

Drug Profile

Nivolumab biosimilar - Xbrane

Alternative Names: Xdivane

Latest Information Update: 07 Apr 2025

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At a glance

  • Originator Xbrane
  • Class Antineoplastics; Antivirals; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • 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

  • Preclinical Bladder cancer; Colorectal cancer; Head and neck cancer; Liver cancer; Lung cancer; Malignant melanoma; Renal cancer; Skin cancer; Urogenital cancer

Most Recent Events

  • 20 Mar 2025 Xbrane expects to have delivered all related documentation to the clinical trial application as well as the clinical trial material to its partner Intas in April 2025
  • 20 Mar 2025 Xbrane plans to submit BLA in the fourth quarter of 2027
  • 19 Nov 2024 Nivolumab biosimilar licensed to Intas Pharmaceuticals worldwide

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