Bioanalytical Method Development and Validation of Biosimilars: Lessons Learned

[1]. In order to evaluate biosimilarity between an innovator and biosimilar product, the FDA recommended a stepwise, riskbased totality of evidence approach. In addition to extensive structural and functional characterization, effort must also be made on preclinical development in terms of animal toxicity studies and the assessment of pharmacokinetics (PK) and immunogenicity. Although there are FDA, EMA guidelines, and whitepapers describing best practices for bioanalytical method development and validation [4-9], there is no clear guidance or recommendation to design and validate bioanalytical assays for biosimilars. The following sections described the experience and lessons we have learned during the course of biosimilar bioanalytical method development and validation.