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      A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.

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          Abstract

          For approval of generic drugs, the U.S. Food and Drug Administration (FDA) requires the evidence of bioequivalence in average bioavailability from the bioavailability/bioequivalence studies. The criterion for assessment of bioequivalence adopted by the FDA is a moment-based criterion evaluating log-transformed pharmacokinetic responses such as area under the blood or plasma concentration-time curve (AUC) or maximum concentration (Cmax). Unlike traditional small molecule drug products, the characteristics and development of biologic products are more complicated and sensitive to many factors. Thus, it is of concern to know whether the current bioequivalence criterion is applicable to the assessment of biosimilarity between biologic products. In this article, we compare the moment-based criterion with a probability-based criterion proposed by Tse et al. (2006) for assessment of bioequivalence or biosimilarity between two drug products in terms of consistency/inconsistency for correctly concluding bioequivalence or biosimilarity. A simulation study was conducted to study relative performance of the two criteria. The feasibility and applicability of the proposed criteria for assessment of biosimilarity of follow-on biologics are discussed.

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          Author and article information

          Journal
          J Biopharm Stat
          Journal of biopharmaceutical statistics
          Informa UK Limited
          1520-5711
          1054-3406
          Jan 2010
          : 20
          : 1
          Affiliations
          [1 ] Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina 27705, USA. sheinchung.chow@duke.edu
          Article
          918539447
          10.1080/10543400903280308
          20077247
          54e7e3a5-b253-4d5b-88bb-a0fa4c2f7876
          History

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