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.
About the Author
Laszlo Endrenyi, Professor Emeritus, University of Toronto
Book Information
ISBN 9780367552497
Author Laszlo Endrenyi
Format Paperback
Page Count 496
Imprint CRC Press
Publisher Taylor & Francis Ltd
Weight(grams) 712g