The European Medicines Agency (EMA) has released for consultation product-specific guidance on bioequivalence studies for four active substances: asenapine maleate, prasugrel hydrochloride, sitagliptin phosphate monohydrate and zonisamide.

This follows the finalisation of bioequivalence guidance which covered 16 active substances in 2014 and 2015.

As part of the development of generic medicines, companies need to demonstrate that the generic and the reference product are bioequivalent, which means that, under similar conditions, they release the same active ingredient into the body at the same rate and level. This is done through bioequivalence studies. Such studies can also be required for example for applications for variations of a marketing authorisation, fixed-dose combinations, extensions of indication and hybrid applications.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002369.jsp&mid=WC0b01ac058004d5c1