Nivolumab Drug Substance Suppliers & Bulk Manufacturers

Available Forms: Drug substance (bulk)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Opdivo

Category: Active Pharmaceutical Ingredient

Nivolumab is a fully human anti-PD-1 IgG4 monoclonal antibody used across many cancers. Its drug substance is sourced by biosimilar developers, CDMOs and research teams.

Product Description:

Nivolumab is a fully human IgG4 kappa antibody that blocks the PD-1 receptor on T cells, releasing a brake on the immune response so the body can attack tumour cells. It is approved in a wide range of cancers, including melanoma, non-small cell lung cancer, pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, MSI-H or dMMR colorectal cancer, hepatocellular carcinoma, and oesophageal, gastric and gastro-oesophageal junction cancers (reference brand: Opdivo).

Specification at a glance

Regulatory files and timing

Biologic drug substance is usually supplied in bulk under a long-term supply agreement, or licensed together with the dossier, rather than bought as a one-off API order. Buyers typically ask for the drug substance comparability package, cell bank and process documentation, and the supplier's GMP status.

Generic or biosimilar entry. United States: Entry expected (2028). European Union: Entry expected (2030). Sources and updates are on our generic and biosimilar entry tracker.

Handling and quality points

Nivolumab drug substance is a protein solution that must be kept refrigerated or frozen, so suppliers need validated cold-chain shipping with temperature logging and data on freeze-thaw and agitation stress. A biosimilar programme depends on matching the reference product's quality attributes, including glycosylation, charge variants, aggregates and PD-1 binding, so analytical comparability data matter as much as the batch certificate. IgG4 antibodies can undergo Fab-arm exchange, so the supplier's characterisation should cover hinge stability.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.