Generic apps down in EU

There appears to be a marked slump in the number of generic-drug applications being submitted to EU regulators. To date, the number of applications started and finalized this year to date are 9 and 12, respectively.  By the same point last year, 38 generic-drug product applications had been filed, according to a PharmTech report analyzing data from the European Medicines Agency.

Generic applications had been on the upswing over the past few years. For example, at the same point in 2007, six applications had been started and five finalized. But the number of applications started jumped to 30 by this point in 2008, and four had been finalized.

In terms of finalized applications, generic and new products are roughly even so far this year, with 12 for generic drugs and 11 for new products, PharmTech notes. A total of 40 applications (generic and innovator) have been filed so far this year, and 30 have been finalized. By this point in 2009, 95 had been started and 125 finalized.

The number of negative opinions has declined from eight in 2009 to just one so far in 2010. The PharmTech report notes that this might seem like a positive, but it may actually be part of a more trend for a lack of marketing authorization applications as a whole. So far for 2010, only 40 new marketing authorization applications have been filed; for 2007, 2008 and 2009, the total number of product applications started was 90, 103 and 95, respectively.

- get more from PharmTech