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.
