Biosimilar Drug Product Development  book cover
1st Edition

Biosimilar Drug Product Development

ISBN 9780367552497
Published June 30, 2020 by CRC Press
496 Pages 14 Color & 31 B/W Illustrations

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Book Description

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.

Table of Contents

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

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Laszlo Endrenyi, Professor Emeritus, University of Toronto