Nivolumab biosimilar - Xbrane
Alternative Names: XdivaneLatest Information Update: 07 Apr 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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