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, extensions of indication and hybrid applications.

The 16 active substances covered by these draft guidance documents are: capecitabine; carglumic acid; dasatinib; emtricitabine/tenofovir disproxil; erlotinib; imatinib; memantine; miglustat; oseltamivir; posaconazole; repaglinide; sirolimus; sorafenib; tadalafil; telithromycin; voriconazole.

Draft capecitabine product-specific bioequivalence guidance
CHMP/PKWP/EMA/423732/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154312.pdf

Draft carglumic acid product-specific bioequivalence guidance
CHMP/PKWP/EMA/422457/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154313.pdf

Draft dasatinib product-specific bioequivalence guidance
CHMP/PKWP/EMA/423718/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154314.pdf

Draft emtricitabine/tenofovir disoproxil product-specific bioequivalence guidance
CHMP/PKWP/EMA/423726/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154315.pdf

Draft erlotinib product-specific bioequivalence guidance
CHMP/PKWP/EMA/418988/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154316.pdf

Draft imatinib product-specific bioequivalence guidance
CHMP/PKWP/EMA/423733/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154317.pdf

Draft memantine product-specific bioequivalence guidance
CHMP/PKWP/EMA/423734/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154318.pdf

Draft miglustat product-specific bioequivalence guidance
CHMP/PKWP/EMA/422796/2013
Date: 14 November 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154319.pdf

Draft oseltamivir product-specific bioequivalence guidance
CHMP/PKWP/EMA/423665/2013
Date: 14 November 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154320.pdf

Draft posaconazole product-specific bioequivalence guidance
CHMP/PKWP/EMA/423719/2013
Date: 14 November 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154321.pdf

Draft repaglinide product-specific bioequivalence guidance
CHMP/PKWP/EMA/422421/2013
Date: 14 November 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154322.pdf

Draft sirolimus product-specific bioequivalence guidance
CHMP/PKWP/422569/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154323.pdf

Draft sorafenib product-specific bioequivalence guidance
CHMP/PKWP/EMA/423707/2013
Date: 24 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154324.pdf

Draft tadalafil product-specific bioequivalence guidance
CHMP/PKWP/EMA/423735/2013
Date: 14 November 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154325.pdf

Draft telithromycin product-specific bioequivalence guidance
CHMP/PKWP/EMA/422605/2013
Date: 14 November 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154326.pdf

Draft voriconazole product-specific bioequivalence guidance
CHMP/PKWP/EMA/422408/2013
Date: 14 November 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154327.pdf

EMA intends these guidelines to enable a consistent approach to the assessment of applications supported by bioequivalence data, particularly generics applications, across all authorization routes, i.e. centralized, decentralized, mutual-recognition and national authorization procedures.

The guidance is intended to help companies design study programmes that meet the expectations of European Union regulators, allowing for better transparency and predictability of the scientific assessment during the authorization process.

For each medicine, the document provides 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.

Comments on the draft guidelines should be made to EMA using the submission form available on the agency’s website and sent no later than 15 February 2014 to pkwpsecretariat@ema.europa.eu.

This is the first wave of product-specific bioequivalence guidance and EMA intends to release more product-specific guidance on the demonstration of bioequivalence in 2014.

Related articles

FDA issues new bioequivalence guidance for generics

EU guidelines for biosimilars

EU guidelines for generics

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