Assessing biosimilarity using the method of generalized pivotal quantities
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 3
Abstract
Introduction: For generic approval of small-molecule (chemical) drug products, US Food and Drug Administration requires evidence of equivalence in average bioavailability from bioavailability and bioequivalence studies. To address drug interchangeability, population bioequivalence (PBE) for drug prescribability and individual bioequivalence (IBE) for drug switchability under replicated crossover designs have been proposed. Methods: In this manuscript, we assess the biosimilarity through a 95% upper confidence bound based on the recommended individual bioequivalence criterion based on method of generalized pivotal quantities (GPQs) under a 2 × 3 extra-reference crossover design. A simulation study is conducted to evaluate performance of GPQ-based approach by using bootstrap procedure. Both methods have almost the same power but GPQ approach controls type I error within the pre-specified significant level. Discussion: It is recognized that standard methods for bioequivalence assessment of small-molecule drug products cannot be directly applied to assessing biosimilarity of biosimilar products owing to some fundamental differences between small-molecule generic and large-molecule biosimilar drug products.GPQ is an appropriate method for assessing biosimilarity of biosimilar drug products under the 2 × 3 extra-reference crossover design.
Authors and Affiliations
Shih-Ting Chiu, Chen Chen, Shein-Chung Chow, Eric Chi
Keywords
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- EP ID EP354890
- DOI 10.5639/gabij.2013.0203.037
- Views 111
- Downloads 0
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