Biosimilarity: The FDA Perspective

by Sarfaraz K Niazi and Sarfaraz K. Niazi

Book Overview

Summary:

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...

• Format: Hardcover
• Language: English
• ISBN: 1498750397
• ISBN13: 9781498750394
• Release Date: July 2018
• Publisher: CRC Press
• Length: 398 Pages
• Weight: 2.40 lbs.
• Dimensions: 1.1" x 7.3" x 10.0"