EMA Issues Product-Specific Bioequivalence Guidance on Four APIs


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-20-2015 14:04

  

The European Medicines Agency (EMA) has released for consultation product-specific guidance on bioequivalence studies for four active substances: asenapine, prasugrel, sitagliptin, and zonisamide. This follows the finalization of bioequivalence guidance that covered 16 active substances in 2014 and 2015. Comments on the draft guidance documents should be submitted no later than November 1, 2015.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 authorization, fixed-dose combinations, extensions of indication, and hybrid applications.

Asenapine is the active ingredient in Allergan's Saphris, a drug to treat bipolar disorder. Prasugel is the active ingredient in Daiichi Sanyko's/Eli Lilly's Effient, an anticoagulant. Sitaliptin is the active ingredient in Merck & Co.'s Januvia, a drug to treat Type II diabetes. Zonisamide is the active ingredient in Eisai's Zonegran, an antiepileptic agent.

The EMA has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorization applications for generic medicines across all authorization routes available in the European Union (i.e., the centralized procedure via EMA and the decentralized, mutual-recognition and national authorization procedures via the national competent authorities). These guidance documents describe the specific requirements for the demonstration of bioequivalence for each active substance. The EMA intends to release product-specific bioequivalence guidance for new substances twice a year.

Source: European Medicines Agency

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