Determining the similarity of a biosimilar to the innovator requires the measurement of both the biosimilar and innovator product in biological matrices for assessment of pharmacokinetic parameters. We offer high quality, sensitive and robust off-the- shelf pre-validated assays for the measurement of biosimilars to support pharmacokinetic studies in both pre-clinical and clinical studies.
All of our methods have been developed and pre-validated using global regulatory guidelines on bioanalytical method validation (e.g. the FDA’s Guidance for Industry: Bioanalytical Method Validation, the EMA’s Guideline on bioanalytical method validation, etc.).
Our scientists have extensive experience and expertise in developing immunoassays in various platforms to support pharmacokinetic studies. In addition to our off-the- shelf biosimilar assays, we can develop custom reagents and assays to support your novel biologics development.
Click on the link below to find some examples of the pre-validated biosimilar pharmacokinetic methods.