Biosimilars: A New Generation of Biologics - Hardcover

Hardcover

ISBN 10: 2817803353 ISBN 13: 9782817803357

Publisher: Springer, 2012

Synopsis

Due to their origins and complexity, biotechnological medicinal products are, compared to chemical products, difficult to reproduce. Now, biotechnological medicinal products, introduced to the market since 1990 are no longer covered by their protection certificates, making it possible to apply for a marketing authorisation for the same active substance as the reference product. In response to this new situation, the European Commission issued a regulation on so-called "medicinal products biologically similar to reference products", creating the regulatory concept of "biosimilar medicinal products." Though the substitution, by the pharmacist, of generic chemical medicinal products is subject to applicable legislation, this is not the case for biosimilars. The decision on the interchangeability of the reference product and its biosimilar is a medical act under the prescriber's responsability. The present work addresses the legal regulatory framework, analyses the contexts of biotechnological medicinal products along with the conditions for their registration, and helps to shed light on the post-market authorization problematic, while also discussing the associated financial costs. It is primarily intended for prescribing doctors and for pharmacists working in hospitals, but also for the broad range of actors in the health sector who want to better understand the emergence of these new medicinal products from the perspective of their prescription and proper utilisation.

About this title

Product Description:

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 Author:

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).

About this edition

• Publisher: Springer
• Publication date: 2012
• ISBN 10: 2817803353
• ISBN 13: 9782817803357
• Binding: Hardcover
• Number of pages: 108
• Editor: Prugnaud Jean-Louis, Trouvin Jean-Hugues