Biosimilar drug product development


Book Section

© 2017 by Taylor & Francis Group, LLC. 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.

Full Text

Duke Authors

Cited Authors

  • Endrenyi, L; Declerck, PJ; Chow, SC

Published Date

  • January 1, 2017

Start / End Page

  • 1 - 477

International Standard Book Number 13 (ISBN-13)

  • 9781498718790

Digital Object Identifier (DOI)

  • 10.1201/9781315119878

Citation Source

  • Scopus