Pharma Focus Asia

Changing Paradigms In Bioequivalence Trials Submitted To The Ema For Evaluation – A Clinical And Regulatory Perspective

Author: Nathaniel Refalo, Daniel Chetcuti, Amy Tanti, Anthony Serracino-Inglott, John Joseph Borg

Abstract:

Background

The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a means to allow companies to reduce costs and reach the market earlier. We therefore investigated whether different approaches in various products assessed by the European Medicines Agency during the approval phase resulted in a reduction in resources required to show bioequivalence for different medicinal products.

Methods

European Public Assessment Reports (EPARs) for off-patent medicinal products authorised within the European Union (EU) through the centralised procedure during the period 2007–2015 were retrieved and reviewed to identify the clinical studies that resulted in fewer number of subjects, the number of centres or trial duration versus the two-period crossover design.

Results

7 studies out of 108 were considered as having benefitted from having a different design. Differences noted included having a different dose allocation scheme, having a different number of dosing periods, having a different number of treatment arms, and having one study evaluating different strengths. Benefits noted included a decrease in the number of subjects and centres required, decreases in study duration and a reduced number of studies required to demonstrate bioequivalence.

Keywords

Marketing authorisation; Generic medicinal products; Bioequivalence

Citation: Nathaniel Refalo, Daniel Chetcuti, Amy Tanti, Anthony Serracino-Inglott, John Joseph Borg Changing Paradigms In Bioequivalence Trials Submitted To The Ema For Evaluation – A Clinical And Regulatory Perspective http://dx.doi.org/10.1016/j.jsps.2016.07.005

Received: 30 March 2016, Accepted: 25 July 2016, Available online: 29 July 2016

Copyright: © 2016 The Authors. Production and hosting by Elsevier B.V. on behalf of King Saud University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Conclusion

Bioequivalence studies can be designed in a specific manner to require fewer resources to carry out. Fewer resources required to register a medicinal product, could impart an advantage to companies (such as to be first on the market) or could even translate to making medicines more accessible (such as cheaper) to patients.

Acknowledgements

This research has received no specific grant from any funding agency in the public or private sector.

The views expressed in this article are the personal views of the authors and may not be used or quoted as being made on behalf of, or reflecting the position of, any national competent authority, the European Medicines Agency, or one of its committees or working parties or any University.

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