398 pages | 79 Color Illus.
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
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