Biosimilar Drug Product Development

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

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


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  • Covers practical issues commonly encountered in biosimilar drug product development
  • Discusses current regulatory thinking concerning the approval pathway of biosimilar products and recent developments of statistical methods for the assessment of biosimilar products
  • Reviews the analytical, animal and clinical development of biosimilars and discusses issues of structural and functional characterization, manufacturing process control, and immunogenicity
  • Discusses post-approval pharmacovigilance, economic and legal considerations, and the extrapolation of indications
  • Provides insightful discussion regarding interchangeability and substitution from statistical, regulatory and clinical perspectives


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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