Biosimilars 2016

Structural and functional characteristics of a protein that can impact clinical activity are understood to be "critical quality attributes," or CQAs. Given the complexity and inherent heterogeneity of protein products, biosimilars will inevitably show some molecular differences when compared to the reference product. The challenge is to demonstrate that the differences that are seen will have no meaningful clinical impact. This session will explore how the knowledge and analysis of CQAs contributes to the overall similarity evaluation; the role that clinical studies can and cannot play in determining similarity; how molecular and clinical knowledge of one product can contribute to the understanding of other products; and how the FDA uses the totality of the analytical, non-clinical, and clinical evidence to determine whether there may be clinically-meaningful differences between a proposed biosimilar and the US-licensed reference product.