This Reflection Paper will discuss the necessity of CES for demonstration of biosimilarity. In order to place those reflections into context, the Reflection Paper will first consider the current practice with respect to analytical comparability exercises, including in vitro pharmacology, and consider their predictive value. Subsequently, some reflections will be provided with regard to the contribution of CES, and other human in vivo studies, especially PK/PD studies, and to the assessment of immunogenicity.
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