Statistical Designs for Assessing Interchangeability of Biosimilar Products
China Lu Y, College of Applied Sciences, Beijing University of Technology, Beijing,Chow SC, Duke University School of Medicine, Durham, North Carolina, USAZhang ZZ, College of Applied Sciences, Communication University of China, Beijing, China
The increasing expiration of patents for various innovator biopharmaceutical and biotech products has prompted a growing interest among companies in obtaining regulatory approval for biosimilar products. However, when more biological products become available after their patent expiration, the question arises regarding the safety and interchangeability of approving these biosimilar products. The United States Food and Drug Administration (FDA) mandates that, for a biological product administered multiple times to an individual, the risks associated with alternating or switching between the biosimilar product and the reference product should not exceed the risks of using the reference product alone. To address this issue, several valuable designs have been proposed to assess drug interchangeability based on the concept of switching and/or alternation. Furthermore, a unified approach is discussed, utilizing the biosimilarity index developed for this purpose. This proposed method demonstrates robustness against biosimilarity criteria and is applicable within a valid and appropriate study design.
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Corresponding Author : |
Lu Y |
Received July 22, 2013; Accepted September 20, 2013; Published October 01, 2013
Citation: Lu Y, Chow SC, Zhang ZZ (2013) Statistical Designs for Assessing Interchangeability of Biosimilar Products. Drug Des 2:109. doi: 10.4172/2169-0138.1000109
Copyright: ? 2013 Lu Y, et al. OMICS Group - Open Access Publisher. 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.
