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Clin Transl Sci. 2019 May 2. doi: 10.1111/cts.12642. [Epub ahead of print]

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications.

Author information

European Medicines Agency, London, UK.
The Spanish Agency of Medicines and Medical Devices, Madrid, Spain.
Federal Institute for Drugs and Medical Devices, Bonn, Germany.
Medicines Evaluation Board, Utrecht, The Netherlands.
Chair of the Pharmacokinetics Working Party of the Committee for Medicinal Products for Human Use at the European Medicines Agency, London, UK.


The waiver of the in vivo demonstration of bioequivalence (biowaiver) is an established tool in drug development and regulatory assessment. This study reviews the use of different biowaiver approaches in centralized applications for marketing authorization to the European Medicines Agency for generic and innovator medicinal products in 2016 and 2017. The focus was to provide insight into the applicability of biowaivers for medicines development. The results show that as expected, biowaivers were most frequently used in applications for generic medicines, in particular for the approval of additional strengths when in vivo bioequivalence has been demonstrated using a single, usually the highest, strength. Biowaivers have, however, also been used in applications for innovator medicines in different phases of clinical development. This review confirms the existing key roles and further potential for biowaivers in regulatory submissions in that they are useful in streamlining the often challenging processes of clinical development.


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