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Nivolumab biosimilar - mAbxience

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Drug Profile

Nivolumab biosimilar - mAbxience

Alternative Names: MB-11

Latest Information Update: 05 Nov 2025

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At a glance

  • Originator mAbxience
  • 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 - Malignant melanoma

Highest Development Phases

  • Phase II Malignant melanoma

Most Recent Events

  • 31 Oct 2025 Nivolumab biosimilar - mAbxience is available for licensing as of 31 Oct 2025. https://mabxience.com/biopharmaceutical-development/#partnership
  • 28 Oct 2025 Phase-II clinical trials in Malignant melanoma (IV), prior to October 2025 (mAbxience pipeline, October 2025)
  • 28 Oct 2025 mAbxience Research S.L. plans the phase III LEON trial for Malignant melanoma (Late-stage disease, Inoperable/unresectable, Metastatic disease, First-line therapy) (IV, Infusion), in October 2025 , (NCT07221734)

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