Abstract
Bioanalysis in biosimilar biological product development (BPD) plays a critical role in demonstrating pharmacokinetic (PK) similarity across products. The 2018 FDA Bioanalytical Method Validation guidance for industry provides general principles in the development, validation, and conduct of bioanalytical assays. Given that the PK similarity assessment in BPD programs involves two or more non-identical products, there are additional considerations for bioanalytical methods. Here in, we provide our perspectives on the definition of (1) a single bioanalytical method in the context of BPD in supporting a PK similarity study, (2) bioanalytical method comparability during accuracy and precision experiments to determine the potential bias difference prior to assessing other validation parameters, and (3) bioanalytical method validations that support PK similarity assessments.
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Acknowledgments
All authors would like to thank Dr. Lauren Milligan, Office of Clinical Pharmacology, FDA for manuscript editing assistance.
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All the work had been completed by T.M.T while in Office of Clinical Pharmacology at FDA. Any additional inquires can be addressed to CDER-OCP-TherapeuticBiologicsProgram@fda.hhs.gov.
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Thway, T.M., Wang, Y.M., Booth, B.P. et al. Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development. AAPS J 22, 15 (2020). https://doi.org/10.1208/s12248-019-0397-8
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DOI: https://doi.org/10.1208/s12248-019-0397-8