Research Article
Statistical Considerations in Biosimilar Assessment Using Biosimilarity Index
Aijing Zhang1, Jung-Ying Tzeng1 and Shein-Chung Chow2*
1Department of Statistics at NC State University, Raleigh, NC 27695, USA
2Department of Bioinformatics and Biostatistics at Duke University, Durham, NC 27708, USA
- *Corresponding Author:
- Shein-Chung Chow
Department of Bioinformatics and Biostatistics
Duke University
Durham, NC 27708, USA
E-mail: [email protected]
Received Date: July 19, 2013; Accepted Date: August 26, 2013; Published Date: September 02, 2013
Citation: Zhang A, Tzeng JY, Chow SC (2013) Statistical Considerations in Biosimilar Assessment Using Biosimilarity Index. J Bioequiv Availab 5:209-214. doi: 10.4172/jbb.1000160
Copyright: © 2013 Zhang A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
When an innovative biologic product goes off patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. Unlike small molecule drug products, biosimilars are not exact copies of their brand-name counterpart, and they are usually very sensitive to changes in environmental factors and have greater variabilities due to their complexity and sensitivity to variation in manufacturing processes. Facing these challenges, a biosimilarity index based on reproducibility probability is proposed to assess biosimilarity. In this article, we have demonstrated how to assess biosimilarity between the test and reference product in relative to a reference standard that is established in a study where reference product is compared with itself. Biosimilairty index approach is robust against biosimilarity criteria and has the advantage of allowing the assessment of the degree of similarity.
