Biosimilar Drug Product Development

by Laszlo Endrenyi (Editor), Dr. Paul Declerck (Editor), Shein-Chung Chow (Editor)

Overview

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Product Details

ISBN-13:	9781498718790
Publisher:	Taylor & Francis
Publication date:	03/07/2017
Series:	Drugs and the Pharmaceutical Sciences
Pages:	496
Product dimensions:	6.12(w) x 9.19(h) x (d)

About the Author

Laszlo Endrenyi, Professor Emeritus, University of Toronto

Table of Contents

Analytical characterization. Immunogenicity. Animal studies. Clinical development. Manufacturing, process control. Extrapolation of indications. Interchangeability, substitution. Pharmacovigilance. Statistical issues. Regulatory issues.