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EMA adopts five product-specific bioequivalence guidelines Posted 11/08/2017

The European Medicines Agency (EMA) has adopted five product-specific guidance documents on the demonstration of bioequivalence. The guidelines were published on 10 July 2017 and will become effective from 1 January 2018.

Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of generic drugs in order to demonstrate that they are bioequivalent to a reference medicine. In general, bioequivalence testing provides a useful comparison for different products containing the same active ingredient. Bioequivalence studies therefore play a key role in the development of new generics, as well as in post-marketing authorization variations, fixed-dose combinations, extension of indications and hybrid applications.

The guidelines cover an HIV antiretroviral therapy (elvitegravir) and combination therapies (elvitegravir/cobicistat/emtricitabine/tenofovir and emtricitabine/rilpivirine/tenofovir), an antidepressant (vortioxetine) and a chemotherapy treatment for non-small cell lung cancer (crizotinib).

The guidance documents are intended to help companies design study programmes that meet the expectations of European Union regulators. It is expected that following the requirements of these guidance documents will ensure that the data submitted in support of a marketing authorization application complies with the appropriate scientific, regulatory and legal requirements.

For each medicine, the documents provide guidance in the form of a table on:

  • biopharmaceutical classification system (BCS)
  • type of bioequivalence study design
  • analyte (parent drug or metabolite) to be evaluated
  • bioequivalence assessment.

The agency is also still reviewing comments from a draft guideline on anticoagulant drug dabigatran. The deadline for comments on the guideline was 31 March 2017.

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EMA releases product-specific bioequivalence guidelines

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Source: EMA

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