ABSTRACT
As indicated in Chow and Liu (2008), the assessment of bioequivalence for small-molecule drug products is performed under the Fundamental Bioequivalence Assumption. This Assumption considers pharmacokinetic responses such as AUC and Cmax as surrogate endpoints for clinical endpoints for the evaluation of the safety and efficacy of the drug products under study. Following a similar idea, statistical methods for the assessment of biosimilarity between a biosimilar product and an innovator product can be derived under a Fundamental Biosimilarity Assumption and a probabilitybased criterion for biosimilarity using biomarker data by assuming that the biomarker is predictive of the clinical outcome of the biological products (Chow et al., 2010).
