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.
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