Special Issue Paper
Article first published online: 30 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 370–381, 10 February 2013
How to Cite
Chow, S.-C., Wang, J., Endrenyi, L. and Lachenbruch, P. A. (2013), Scientific considerations for assessing biosimilar products. Statist. Med., 32: 370–381. doi: 10.1002/sim.5571
- Issue published online: 10 JAN 2013
- Article first published online: 30 AUG 2012
- Manuscript Received: 26 JUL 2012
- Manuscript Accepted: 26 JUL 2012
- follow-on biologics;
- drug interchangeability;
The problem for assessing biosimilarity and drug interchangeability of follow-on biologics (biosimilar products) is studied. Unlike the generic products, the development of biosimilar products is much more complicated because of fundamental differences in functional structures and manufacturing processes. As a result, the criteria and standard methods for the design and analysis of bioequivalence assessment of generic drug products may not be directly applicable to assessing biosimilarity of biosimilar products. In this article, we provide some scientific considerations for criteria, design, and analysis regarding the assessment of biosimilarity and drug interchangeability of biosimilar products. In addition, we discuss scientific and practical issues raised at the 2010 FDA public hearing and the 2011 FDA public meeting on biosimilar products. Copyright © 2012 John Wiley & Sons, Ltd.