Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development

Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs• Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible• Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information• Examines new technologies and strategies for improving biosimilar mAbs