Biosimilar Drug Product Development: 1st Edition (Hardback) book cover

Biosimilar Drug Product Development

1st Edition

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

CRC Press

477 pages | 14 Color Illus. | 31 B/W Illus.

Purchasing Options:$ = USD
Hardback: 9781498718790
pub: 2017-03-07
eBook (VitalSource) : 9781315119878
pub: 2017-02-24
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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.

About the Series

Drugs and the Pharmaceutical Sciences

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Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
MEDICAL / Pharmacy
SCIENCE / Chemistry / General