Biosimilar Drug Product Development

1st Edition

Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow

CRC Press
Published March 7, 2017
Reference - 477 Pages - 14 Color & 31 B/W Illustrations
ISBN 9781498718790 - CAT# K25468
Series: Drugs and the Pharmaceutical Sciences

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Summary

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.

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