ABSTRACT
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
chapter 5|23 pages
Manufacturing and Process Control Issues
Quality Development of Biosimilar Medicinal Products
chapter 9|19 pages
Extrapolation of Indications for Biosimilars
Opportunity for Developers and Challenges for Regulators
