As biosimilar compounds are not exact duplicates of innovator biotherapeutics, regulatory agency requirements for biosimilar compounds differ from those of small molecules. One differentiator is the required evaluation of biosimilar ‘similarity’ compared to the innovator biologic compound. In general, LBA requires one (in the case of competitive assays) or two (in the case of a sandwich assay) binding reagents (critical reagents) to measure the biotherapeutic. The specificity and selectivity of the assay is dependent on the interaction of these binding reagents to the biotherapeutic. It is possible that the innovator and the biosimilar do not have the same binding characteristics towards the assay critical reagents. In this case, two assays with different critical reagents may be used: reagents of the innovator vs reagents of the biosimilar. Unlike LBA approaches, LCMS assays for biosimilar bioanalysis can be developed without using LBA critical reagents. Hence, only a single LCMS assay is needed for both biosimilar and innovator comparison.
What you will learn?
- Regulatory requirements and guidelines relevant for the development of biosimilar products and impact on bioanalysis and immunogenicity
- Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development
- LCMS ability to provide in depth information to evaluate ‘the similarity’ of biosimilar and innovator drugs
- Development of LCMS assays for biosimilars without using critical reagents to avoid different binding characteristics between the biosimilar and the innovator
- Case studies: peptides mapping comparison of the biosimilar with the innovator drug; application of one single LCMS assay for both biosimilar and innovator
Who may this interest?
- Generic companies developing biosimilars
- Scientists and managers involved in bioanalysis, immunogenicity and characterization of biosimilars
Jonathan St-Germain obtained his PhD in biochemistry from the University of Toronto (Toronto, Canada), before joining the Research and Development team at Algorithme Pharma (Laval, Canada) as Senior Scientist, LC-MS Large Molecule Quantification, within the Method Development group. Over the years, Jonathan has acquired extensive experience in the global and targeted quantification of proteins and their post-translational or chemical modifications using mass spectrometry and other biochemical tools. His work in this field has been published in various peer-reviewed journals, and presented at international events.
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