For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared to the reference product. Therefore, pharmacokinetic (PK) and immunogenicity (antidrug antibody, ADA) assays that allow for the demonstration of biosimilarity are critical. Under the auspices of the American Association of Pharmaceutical Scientists (AAPS) Ligand-Binding Assay Bioanalytical Focus Group (LBABFG), a Biosimilars Action Program Committee (APC) was formed in 2011. The goals of this Biosimilars APC were to provide a forum for in-depth discussions on issues surrounding the development and validation of PK and immunogenicity assays in support of biosimilar drug development and to make recommendations thereof. The Biosimilars APC’s recommendations for the development and validation of ligand-binding assays (LBAs) to support the PK assessments for biosimilar drug development are presented here. Analytical recommendations for the development and validation of LBAs to support immunogenicity assessments will be the subject of a separate white paper.
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This article represents the scientific opinion of many experts and, in particular, is derived from a series of workshops held under the auspices of the AAPS Ligand-Binding Assay Bioanalytical Focus Group Biosimilars Action Program Committee. It is now presented as an AAPS white paper to support activities, programs, and decisions in the scientific, technical, and regulatory community. Even though it is a final white paper, the authors expect further progress to be made rapidly in this evolving field when this paper is published. Thus, comments and additional contributions are welcome and may be considered for a revision of the position paper in due course.
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Marini, J.C., Anderson, M., Cai, XY. et al. Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments. AAPS J 16, 1149–1158 (2014). https://doi.org/10.1208/s12248-014-9669-5
- bioanalytical method validation
- biological product
- ligand-binding assay