Special Issue Paper
Article first published online: 17 AUG 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Statistics in Medicine
Special Issue: Assessing Biosimilarity and Interchangeability of Biosimilar Products
Volume 32, Issue 3, pages 442–448, 10 February 2013
How to Cite
Chow, S.-C., Yang, L.-Y., Starr, A. and Chiu, S.-T. (2013), Statistical methods for assessing interchangeability of biosimilars. Statist. Med., 32: 442–448. doi: 10.1002/sim.5566
- Issue published online: 10 JAN 2013
- Article first published online: 17 AUG 2012
- Manuscript Received: 26 JUL 2012
- Manuscript Accepted: 26 JUL 2012
Article first published online: 24 JAN 2013
- follow-on biologics;
Unlike traditional small molecule (chemical) drug products, the development of biologic products is very different and variable with respect to the manufacturing process and environmental factors such as light and temperature. The complexity and heterogeneity of the molecular structure, complicated manufacturing process, different analytical methods, and possibility of severe immunogenicity reactions make quantitative evaluation of follow-on biologics a great challenge to both scientific community and regulatory agencies. In this article, we propose a general approach for development of a biosimilarity index based on the concept of reproducibility probability for quantitative evaluation of biosimilarity and interchangeability. The proposed method is robust regardless the biosimilarity criteria used and/or study design employed. Copyright © 2012 John Wiley & Sons, Ltd.