Browsing: Bioanalysis for Biosimilars Development


ISBN: 978-1-910419-33-5 (Online)

Editor: Paul Declerck (University of Leuven)

This entry is part 5 of 10 in the series Bioanalysis for Biosimilars Development

In this chapter three cases of submitted biosimilar applications are discussed. The aim of the examples and following discussion is to provide insight into the uncertainty that still remains over several factors, including the level of biosimilarity that is deemed acceptable and how to address differences identified during comparative studies.