Cetuximab Biosimilar PK Assay
A diverse set of methods to evaluate comparability of both the biosimilar drug and it's clinical performance
Cetuximab (Erbitux®) is a chimeric (mouse/human) IgG1 monoclonal antibody targeted against the epidermal growth factor receptor (EGFR). It is used for the treatment of metastatic colorectal cancer and squamous cell carcinoma of the head and neck in conjunction with radiation and chemotherapy. The half life of cetuximab is approximately 112 hours.
Evaluation of the comparability of cetuximab 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 of off-the-shelf cetuximabpharmacokinetic assay for comparability testing of biosimilars:
Representative standard curve for detection of cetuximab in human serum. Standard range tested 21 - 1,200 ng/ml of cetuximab in human serum matrix.
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