Biosimilarity

The FDA Perspective

Sarfaraz K. Niazi (Therapeutic Proteins International, LLC, USA)

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Paperback

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English

CRC Press
02 October 2023

Pharmaceutical technology

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 complexity -- a must for every developer of biosimilars.

Features:

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

By: Sarfaraz K. Niazi (Therapeutic Proteins International LLC USA)
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 254mm, Width: 178mm,
Weight: 1.000kg
ISBN: 9781032652351
ISBN 10: 1032652357
Pages: 436
Publication Date: 02 October 2023
Audience: College/higher education , Professional and scholarly , Further / Higher Education , Undergraduate
Format: Paperback
Publisher's Status: Active

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