Biosimilars

A New Generation of Biologics

Editors: Prugnaud, Jean-Louis, Trouvin, Jean Hugues (Eds.)

  • Analysis of the complete legal and regulatory framework
  • Approach of the context of copies of biology and biotechnology drugs
  • Details the registration conditions
  • Analysis of these drugs’ marketing (drug safety, prices and distribution channels, substitution and interchangeability…)
  • Investments’ costs and returns on investments are also pointed out
  • A section is focused on the US approach
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  • ISBN 978-2-8178-0336-4
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Hardcover $169.00
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  • ISBN 978-2-8178-0335-7
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  • Usually dispatched within 3 to 5 business days.
Softcover $169.00
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  • ISBN 978-2-8178-0514-6
  • Free shipping for individuals worldwide
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About this book

Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities.

 

In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature.

 

This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.

About the authors

Jean-Louis Prugnaud is a pharmacist, former head of pharmacy department at Saint-Antoine Hospital, Paris, France. He is Member of the French Commission of drugs’ distribution authorization, President of the Commission of gene and cellular therapy and President of the pharmaceutical working group on biological and biothechnological drugs. Jean-Hugues Trouvin works at AFSSAPS (French health products safety agency) and at the pharmaceutical and biological sciences department at the Paris Descartes University in Paris, France. Preface: Christian K. Schneider is Chairman, CHMP of the Similar Biological (Biosimilar) Medicinal Products Working Party (BMWP), member of the European Medicines Agency( London, United Kingdom) and works at the Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines (Langen, Germany) and at the Centre for Experimental and Clinical Infection Research (Hannover, Germany).

Table of contents (7 chapters)

  • Biologicals’ Characteristics

    Ho, K. (et al.)

    Pages 1-22

  • From the Biosimilar Concept to the Marketing Authorisation

    Pavlovic, M. (et al.)

    Pages 23-36

  • Immunogenicity

    Prugnaud, J.-L.

    Pages 37-46

  • Substitution and Interchangeability

    Prugnaud, J.-L.

    Pages 47-52

  • G-CSFs: Onco-Hematologist’s Point of View

    Kamioner, D.

    Pages 53-60

Buy this book

eBook $129.00
price for USA (gross)
  • ISBN 978-2-8178-0336-4
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $169.00
price for USA
  • ISBN 978-2-8178-0335-7
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $169.00
price for USA
  • ISBN 978-2-8178-0514-6
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Rent the eBook  
  • Rental duration: 1 or 6 month
  • low-cost access
  • online reader with highlighting and note-making option
  • can be used across all devices
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Bibliographic Information

Bibliographic Information
Book Title
Biosimilars
Book Subtitle
A New Generation of Biologics
Editors
  • Jean-Louis Prugnaud
  • Jean Hugues Trouvin
Copyright
2012
Publisher
Springer-Verlag Paris
Copyright Holder
Springer-Verlag France
eBook ISBN
978-2-8178-0336-4
DOI
10.1007/978-2-8178-0336-4
Hardcover ISBN
978-2-8178-0335-7
Softcover ISBN
978-2-8178-0514-6
Edition Number
1
Number of Pages
XVIII, 90
Additional Information
Original French edition published by Springer-Verlag, Paris, 2011
Topics