EMA releases first bioequivalence guidance

Published: 5-Dec-2013
Regulatory Pharmaceutical

To help generic medicine manufacturers show that their products are similar to a reference medicine


The European Medicines Agency (EMA) has released its first product-specific guidelines on how pharma companies can demonstrate an active substance has bioequivalence with another.

The aim is to help generic medicine manufacturers show that their products are similar to a reference medicine, aiding marketing-authorisation variations, fixed-dose combinations, and extensions of indication and hybrid applications.

EMA’s first tranche of advice covers 16 active substances: capecitabine; carglumic acid; dasatinib; emtricitabine/tenofovir disproxil; erlotinib; imatinib; memantine; miglustat; oseltamivir; posaconazole; repaglinide; sirolimus; sorafenib; tadalafil; telithromycin; and voriconazole.

The Agency said 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 authorisation process.

For instance, looking at capecitabine, the giuidance recommended that test subjects should be fed 'to minimise the risk of vomiting'. It wants one single dose study that needed tight testing limits, because 'capecitabine is considered a ‘critical dose’ drug'. EMA said more guidance would be released in 2014.

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