Biosimilars 2016

In the US, Europe, and other regions, biosimilarity is demonstrated through a totality of evidence approach. This session will examine the picture of biosimilarity presented by the components of evidence, including the foundations laid by CMC/analytics, non-clinical data, analysis of critical quality attributes (CQAs), and clinical data to address the clinical relevance of differences, from the perspectives of the regulator and of industry. What is the regulator’s view of the organizing framework and how the data work together to demonstrate biosimilarity, especially for complex biologics? From the industry view, when is stepwise development preferable to a parallel development process, and how is decision making, about residual uncertainty or risk for example, influenced by each of these paradigms? What does the totality of evidence mean for development versus marketing applications? Global regulators will join the session speakers in an interactive panel discussion to address audience questions.