Bevacizumab Biosimilar Assays

A diverse set of methods to evaluate comparability of both the biosimilar drug and it's clinical performance

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Bevacizumab (Avastin^®) is a recombinant humanized monoclonal antibody that inhibits angiogenesis by binding to the vascular endothelial growth factor A (VEGF-A). Bevacizumab contains human IgG1 framework regions (93%) and the complementarity-determining regions (CDR) of a murine antibody (7%) that binds to VEGF. Bevacizumab binds to VEGF extracellularly to prevent interaction with VEGF receptors (VEGFR) on the surface of endothelial cells, thereby inhibiting stimulation of new blood vessel formation.

Bevacizumab is currently licensed to treat various cancers, including colorectal, lung, breast (outside the USA), glioblastoma (USA only), kidney and ovarian

Evaluation of the comparability of bevacizumab biosimilars to the innovator drug should follow the guidelines laid out by the FDA and EMA. The analysis should be multifactorial, taking into account both the physicochemical characteristics and clinical performance of the biosimilar compared to the innovator. Eurofins Bioanalytical Services offers a range of off-the-shelf bevacizumab assays for comparability testing of biosimilars including:

Clinical Assays

Bevacizumab PK Assay
An ELISA for the Quantitative Determination of Free and Partially Bound Bevacizumab in Human Serum

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Bevacizumab ADA
A Novel Solution Phase Bridging Assay for the Detection of Antibodies to Bevacizumab in Human Serum in the Presence of Bevacizumab and Soluble VEGF Target

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Drug Assays

Fc Receptor Binding
Methods to Determine the Binding of Bevacizumab to Fc receptors

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Beva

Representative standard curve for detection of bevacizumab in human serum.

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