EMA consults on a new batch of specific guidance for four active substances

The European Medicines Agency has released for consultation product-specific guidance on bioequivalence studies for four active substances.

The now off-patent drugs in question are: asenapine (branded product Sycrest from Merck & Co), prasugrel (Effient, from Daiichi Sankyo and Eli Lilly), sitagliptin (Januvia from Merck & Co) and zonisamide (Zonegran, from Eisai). This follows the finalization 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.