ABSTRACT
Like bioequivalence assessment for the generic approval of small-molecule drug products, the process for assessing the biosimilarity of biosimilar products includes endpoint selection, criteria for biosimilarity, study design, statistical methods for data analysis, and regulatory submission, review, and approval. As indicated in the previous chapters, biosimilar products are made of living cells or organisms with mixed, complicated structures which are difficult, if not impossible, to characterize fully. Thus, standard methods for the assessment of bioequivalence for small-molecule drug products cannot be appropriately and directly applied to assess biosimilarity. Besides, biosimilar products are known to be sensitive to environmental factors such as light and temperature as a small change or variation at any critical stage of the manufacturing process could result in a drastic change in clinical outcomes.
