Chapter 7. Biogeneric Drugs

  1. Dr. Oliver Kayser,
  2. Prof. Dr. Rainer H. Müller
  1. Dr. Walter Hinderer

Published Online: 28 JAN 2005

DOI: 10.1002/3527602410.ch7

Book Title

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Additional Information

How to Cite

Hinderer, W. (2005) Biogeneric Drugs, in Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications (eds O. Kayser and R. H. Müller), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, FRG. doi: 10.1002/3527602410.ch7

Editor Information

  1. Free University Berlin, Institute of Pharmacy, Pharmaceutical Technology, Biopharmacy & Biotechnology, Kelchstr. 31, 12169 Berlin, Germany

Author Information

  1. BioGeneriX AG, Janderstraße 3, 68199 Mannheim, Germany

Publication History

  1. Published Online: 28 JAN 2005
  2. Published Print: 28 JAN 2004

ISBN Information

Print ISBN: 9783527305544

Online ISBN: 9783527602414

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CHAPTER TOOLS

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Keywords:

  • pharmaceutical biotechnology;
  • biogeneric drugs;
  • recombinant therapeutic proteins;
  • biogenerics;
  • biogeneric targets;
  • erythropoietin (EPO);
  • colony-stimulating factors (CSFs);
  • human growth hormone (hGH);
  • insulins;
  • hepatitis B vaccine;
  • factor VIII (FVIII);
  • interferons (IFN);
  • biogeneric developments

Summary

  • Introduction

  • Recombinant Therapeutic Proteins

  • Definition of Biogenerics

  • Regulatory Situation

  • Patent Situation

  • Biogeneric Targets: First Wave

    • Erythropoietin (EPO)

    • Colony-stimulating Factors (CSFs)

    • Human Growth Hormone (hGH)

    • Insulins

    • Hepatitis B Vaccine

    • Factor VIII (FVIII)

    • Interferons (IFN)

  • Biogeneric Developments and its Requirements

    • Process Development

    • Development of Analytical Methods

    • Preclinical and Clinical Development

  • Conclusions

  • References

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