Biosimilars

'Biosimilars' are copies of biological medicinal products no longer protected by certification. Detailing new EU legal and regulatory frameworks on biosimilars, this book also analyzes their safety, marketing, and funding, and includes a section on US rules.

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.

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 Includes supplementary material: sn.pub/extras

Autorentext
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).

Inhalt
Preface: Biosimilars a philosophy?.- Foreword.- 1. Biosimilars characteristics.- Introduction : from generics to biosimilars.- Definitions.- Complexity of biologics and examples.- Conclusion.- 2. From the biosimilar concept to the Marketing Approval. Introduction.- Definition of biosimilars.- Pharmaceutical approval's framework.- Quality control approach.- Non clinical and clinical aspects.- Recommendations in onco-hematology.- Other recommendations.- Conclusion.- 3. Immunogenicity.- Introduction.- Immune mechanisms.- Usual immune response.- Immunologic tolerance breakdown response.- Factors influencing immunogenicity.- Case of monoclonal antibodies.- Conclusion.- 4. Substitution and interchangeability.- **Introduction.- Generics and biosimilars' substitution.- What about biosimilar medicinal products ?.- Interchangeability: suggested definition.- Biosimilars' interchangeability and conditions to be implemented.- Interchangeability practices.- Conclusion.- 5. Onco-hematologist point of view GCSFcase.- **Biosimilars.- Conclusion.- 6. The oncologist's point of view.- Introduction.- Erythropoiesis-stimulating Agents (ESA).- Biosimilars.- Conclusion.- 7. Challenges posed by biosimilars: who isresponsible for cost and risk management.- Introduction.- General information on cost management.- Savings linked to the purchase of biosimilars.- General information on risk management responsibility.- Conclusion.