1st Edition

The FDA Perspective

ISBN 9781498750394
Published July 25, 2018 by CRC Press
436 Pages 79 Color Illustrations

USD $200.00

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Book Description


The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity.  An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars.


First comprehensive analysis based on new guidelines and approval packages of several biosimilars

Presents the first approach to challenge FDA in reducing or eliminating any testing in patients.

Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines

Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies

Allow creation of a fast-to-market pathway to develop biosimilars

Table of Contents

Current Status of Biosimilar Biological Products. The FDA Position. Biosimilarity Tetrahedron. Analytical and Functionality Similarity. Non-clinical Assessment. Clinical Pharmacology Assessment. Clinical Studies. Interchangeability Status. Comprehensive Presentation

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Sarfaraz K. Niazi Ph.D,  is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc.