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Research Article

Statistical Designs for Assessing Interchangeability of Biosimilar Products

Lu Y1*, Chow SC2 and Zhang ZZ3
1College of Applied Sciences, Beijing University of Technology, Beijing, China
2Duke University School of Medicine, Durham, North Carolina, USA
3College of Applied Sciences, Communication University of China, Beijing, China
Corresponding Author : Lu Y
College of Applied Sciences
Beijing University of Technology
Beijing, China
E-mail: zhton[email protected]
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 3:109. doi:10.4172/2169-0138.1000109
Copyright: © 2013 Lu Y, 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.


More and more biopharmaceutical and/or biotech companies begin to concern regulatory approval of biosimilar products, due to some innovator products will expire in decades. Once more biological products are going off patient, the problem whether approving biosimilar products used interchangeably and safely will be considered. Using a biological product of the reference product interchangeably, the United States Food and Drug Administration (FDA) requires that, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product, is not greater than the risk of using the reference product without such alternation or switch. For this purpose, based on the concept of switching and/or alternation several useful designs for assessing drug interchangeability are proposed. In addition, by developed biosimilarity index, a uni?ed approach is discussed. The proposed method is robust against biosimilarity criteria and is applicable under a valid and appropriate study design.

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