12. Safety of Biotherapeutics

  1. John Talbot4,5 and
  2. Jeffrey K. Aronson6
  1. Andrew Erdman1,
  2. James Nickas2 and
  3. Benton Brown3

Published Online: 30 JAN 2012

DOI: 10.1002/9780470975053.ch12

Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition

Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition

How to Cite

Erdman, A., Nickas, J. and Brown, B. (2011) Safety of Biotherapeutics, in Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition (eds J. Talbot and J. K. Aronson), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470975053.ch12

Editor Information

  1. 4

    University of Hertfordshire, College Lane, Hatfield AL10 9AB, UK

  2. 5

    Patient Safety, AstraZeneca R&D, Loughborough, LE11 5RH, UK

  3. 6

    University of Oxford Department of Primary Health Care, Oxford, UK

Author Information

  1. 1

    Amgen, 1120 Veterans Blvd, South San Francisco, CA 94080, USA

  2. 2

    Pharmacovigilance, BioMarin, 105 Digital Drive, Novato, CA 94949, USA

  3. 3

    Global Drug Safety, Celgene, 86 Morris Ave, Summit, NJ 07901, USA

Publication History

  1. Published Online: 30 JAN 2012
  2. Published Print: 2 DEC 2011

ISBN Information

Print ISBN: 9780470986349

Online ISBN: 9780470975053

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Keywords:

  • bioctechnology;
  • biotherapeutics;
  • monoclonal antibodies;
  • protein molecules;
  • recombinant techniques

Summary

The first decade of the 21st century has seen an explosion in the number and breadth of new medicines derived from biotechnology. However, the resulting biotherapeutic products are less well understood than their small molecule counterparts. Whereas small molecules extracted naturally from plants have been used to treat all sorts of maladies for centuries, and chemically created medicines have been the mainstay of pharmaceutical company activity for decades, biotherapeutics have only begun to be used therapeutically within the last 25 years. However, with the sequencing of the human genome and the corresponding increase in our understanding of the cellular basis of disease, the number of biotherapeutics currently approved for use and in clinical development has increased markedly. Knowledge of the specific properties and safety profiles of biotherapeutics has become increasingly important for health-care providers, patients, and drug developers alike. While each individual molecule will obviously have a unique adverse effects profile, having a working knowledge of the types of adverse reactions to be expected from biotherapeutics will ultimately benefit patients and companies alike.