EMA figures demonstrate generic dominance

Pharmaceutical Technology Europe

Figures published by the European Medicines Agency (EMA) relating to centralized procedure activities for human medicines show a significant increase in the number of positive opinions made between 2007 and 2009; however, the majority of approvals are for generic products.

Figures published by the European Medicines Agency (EMA) relating to centralized procedure activities for human medicines show a significant increase in the number of positive opinions made between 2007 and 2009; however, the majority of approvals are for generic products.

According to the data, the number of positive approvals issued by the EMA has increased year on year — 58 in 2007, 66 in 2008 and 117 in 2009. However, the statistics also show that the number of marketing authorization applications for new products has decreased, with only 35 applications started in 2009 compared with 59 in 2007.

Generics, on the other hand, have flourished with 38 marketing authorization applications started in 2009, compared with 30 in 2008 and only 6 in 2007. The number of finalized marketing authorization applications has also significantly increased from 5 in 2007 and 4 in 2008 to more than 50 in 2009.

Meanwhile, marketing authorization applications for orphan products have remained very stable with 11 applications started in 2007, 2008 and 2009. The number of negative opinions issued in each has also remained very stable with 7 in 2007, 7 in 2008 and 8 in 2009.

The data were published on the EMA's website alongside figures relating to January 2010. The agency said that it will be publishing statistics every month to provide ongoing factual information about centralized procedure activities for human medicines.

So what do January 2010's statistics show? The agency has already started eight marketing authorization applications and also issued three positive opinions — two of which are for an orphan product and a generic product. As of yet, no negative opinions have been given, although three applications have been withdrawn prior to opinion.

According to the EMA, the figures complement the CHMP monthly report and will be published on the EMA's website within two weeks following the end of the CHMP meeting.

Commentaries and analysis of the figures will be provided in the agency's annual reports.

www.ema.europa.eu