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
Related Articles
- EP ID EP354890
- DOI 10.5639/gabij.2013.0203.037
- Views 90
- Downloads 0
ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities
The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scient...
The potential for doctors to contribute to biosimilar guidelines
Many healthcare professionals remain concerned about the safety and efficacy of biosimilars, and are hence reluctant to prescribe them for patients, despite the publication of guidelines for their approval by European re...
Licensing and prescribing biosimilars in Australia
Some years ago, Australian regulatory authorities decided to follow the path laid down by the European Medicines Agency in adopting a process for approval of biosimilars. This has been a largely successful process, resul...
Promoting access to biosimilars: a public−private partnership model for biosimilar development in underserved populations
Biologicals represent the future of pharmaceutical treatments and innovation. Yet, emerging and developing markets lack access to these often essential medicines. Biosimilar development represents a potential solution to...
Why bioequivalence and unconditional interchangeability of generic drugs are not the same
The patents for a number of cornerstone immunosuppressive drugs used in the field of solid organ transplantation have expired. Generic formulations are now available and several professional societies and individual phys...