Non-Biological Complex Drugs

The Science and the Regulatory Landscape

  • Daan J.A. Crommelin
  • Jon S. B. de Vlieger

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 20)

Table of contents

  1. Front Matter
    Pages i-ix
  2. Daan J. A. Crommelin, Jon S. B. de Vlieger, Stefan Mühlebach
    Pages 1-8
  3. Non Biological Complex Drugs

    1. Front Matter
      Pages 9-9
    2. Ethlinn V.B. van Gaal, Daan J.A. Crommelin
      Pages 11-76
    3. Daan J.A. Crommelin, Josbert M. Metselaar, Gert Storm
      Pages 77-106
    4. Vera Weinstein, Rivka Schwartz, Iris Grossman, Benjamin Zeskind, J. Michael Nicholas
      Pages 107-148
    5. Stefan Mühlebach, Beat Flühmann
      Pages 149-170
    6. Gerrit Borchard
      Pages 171-189
  4. Characterization of NBCDs; Analytical Tools to Consider

    1. Front Matter
      Pages 191-191
    2. Vishakha V. Ambardekar, Stephan T. Stern
      Pages 261-287
  5. Closely related Complex Drugs

    1. Front Matter
      Pages 289-289
    2. Isabel Rodrigo, Sofía Caruncho, Concepción Alonso, Antonio Gómez-Outes, Barbara Mulloy
      Pages 291-331
  6. Regulatory landscape and outlook

  7. Back Matter
    Pages 389-390

About this book


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. 


Iron carbohydrate complexes Liposomes albumin-cytostatic complexes glatiramoids nanomedicines nanosimilars polymeric micelles regulatory framwork generic drugs and biosimilars

Editors and affiliations

  • Daan J.A. Crommelin
    • 1
  • Jon S. B. de Vlieger
    • 2
  1. 1.Utrecht UniversityUtrechtThe Netherlands
  2. 2.Top Institute Pharma NBCD Working GroupLeidenThe Netherlands

Bibliographic information