Author:
Edition: 2012
Publisher: Springer
Binding: Hardcover
ISBN: 2817803353
Biosimilars: A New Generation of Biologics
Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. Medical books Biosimilars. 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” Medical books Biosimilars: A Generation Of Biologics By Hardcover Book (english). Store Search search Title, ISBN and Author Biosimilars: A New Generation of Biologics Estimated delivery 3-12 business days Format Hardcover Condition Brand New 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. Publisher Description Due to their origins and complexity, biotechnological medic
Download link for Biologics and Biosimilars: Balancing Incentives for ..., 9781240556885
Store Search search Title, ISBN and Author Biosimilars: A New Generation of Biologics Estimated delivery 3-12 business days Format Hardcover Condition Brand New 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. Publisher Description Due to their origins and complexity, biotechnological medic
Bibliogov 9781240556885 Biologics and Biosimilars: Balancing Incentives for Innovation Description The BiblioGov Project is an effort to expand awareness of the public documents and records of the US Government via print publications. In broadening the public understanding of government and its work, an enlightened democracy can grow and prosper. Ranging from historic Congressional Bills to the most recent Budget of the United States Government, the BiblioGov Project spans a wealth of governm
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 biologic
In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biologic
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 refere
Medical Book Biosimilars
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.
