The rise of bio- and nano-technology in the last decades has led to the emergence of a new and
unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates
the challenges associated with NBCD development as well as the complexity of assessing the
effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches
upon proven marketing authorization requirements for biosimilars that could be effective in
evaluating follow-on NBCDs including a demonstration of control over the manufacturing process
and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is
meant to be used for years to come as a standard reference work for the development of NBCDs.
Moreover this book aims to stimulate discussions and further our thinking to ensure that
decisions regarding the approval of complex drugs are made with relevant scientific data on the
table.
