As the patents for biopharmaceuticals first marketed in the 1990s begin to expire, there is an opening for generic or non-proprietary versions of these agents to enter the market. The collective revenues of patent-expired biotech industry now total $10 billion annually, yet biosimilar generics have been slow to arise. It is a situation that has drawn much concern from generic and branded drug developers, patient groups, regulatory agencies and lawmakers. The 2012 release of FDA’s guidance on biosimilar drug development further stresses the need for a technical yet practical guide to biosimilar drug development.

Arising from this landscape, Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing and Preclinical and Clinical Development gives pharmaceutical and biotech scientists and researchers a clear resource to understand the scientific principles and challenges involved in biosimilar drug development.

The book discusses the scientific background including history, classification, and biological activities – including background knowledge unique to monoclonal antibody (mAb) drugs and essential profiling characteristics that regulations require. Contributing authors from the frontlines of biosimilar development address the processes and issues involved with manufacturing biosimilar mAbs, like cell line development, process development, large-scale cell culture of mammalian cells, and final product analysis.

A valuable for all those –  from beginners to experts – with an interest in biosimilar drug development of monoclonal antibodies, Biosimilars of Monoclonal Antibodies:

• Covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing
• Introduces key topics of bioanalytical development, preclinical and clinical validation of biosimilarity, regulatory issues, and legal considerations concerning approval and commercialization
• Leads readers to think beyond biosimilars by examining new technologies and strategies for improving biosimilar mAbs
• Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information
• Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible