The determination of similarity for biosimilars is not only based on the assessment of the degree to which pharmacokinetic and efficacy parameters are equivalent, but also of the relative immunogenicity profiles of the innovator and biosimilar. Robust immunogenicity assays are critical to biosimilar success as it is reported that ore than one third of the biosimilar have ben rejected due to poor immunogenicity assays.
We offer high quality, sensitive and robust pre-validated methods for the measurement of anti-drug antibodies (i.e. both anti-innovator and anti-biosimilar) in biological matrices. All of our methods have been developed and validated as per global regulatory guidelines on immunogenicity method validation (e.g. the FDA’s Guidance for Industry: Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins). And industry best practices.
Our scientists have extensive experience and expertise in developing immunoassays in various platforms for the assessment of immunogenicity. In addition to our pre-validated methods, we can develop custom reagents (such as positive control) and custom methods to support novel biologics development.
Click on the link below to find some examples of the pre-validated biosimilar pharmacokinetic methods.