Biophysical Characterization: An Integral Part of the “Totality of the Evidence” Concept

In this last chapter, we would like to conclude this book by focusing our attention on discussions concerning the integral role that biophysical characterization plays in the concept of the “Totality of the Evidence” (officially introduced on February 9, 2012, by the US Food and Drug Administration, FDA). This concept not only underscores how the FDA will evaluate biosimilars, but more broadly represents how the FDA evaluates all therapeutic compounds submitted for drug approval. In so doing, we have also added some of our own thoughts as to what issues need to be addressed to further enhance the beneficial role of biophysical characterization. As a result, in writing this chapter we have revisited some of the earlier discussions made in Section I of this book to briefly summarize the role that biophysical characterization plays in developing biopharmaceuticals. Such redundancy we feel is worthwhile in trying to bring clarity to the expectations to what can be achieved today and what needs to be improved to do a better job (in developing biopharmaceuticals) for tomorrow.