EU Generic Applications Down

Aug 18, 2010

Recent figures published by EMA relating to centralized procedure activities for human medicines appear to show a marked slowdown in the number of generic-drug applications filed and finalized this year to date (9 and 12, respectively). Although this number will undoubtedly increase by the end of the year, a marked difference is already evident in comparison to 2009, when 38 generic-drug product applications were filed.

Despite many in the industry believing that generic drugs are beginning to dominate with more products going off patent, the figures for 2010 show a different story. Generic drugs clearly dominated 2009, but for 2010 they appear to be lagging markedly behind with only nine generic-drug product applications filed versus 20 applications for new products. In terms of finalized applications, generic drugs and new products are roughly even so far with 12 for generic drugs and 11 for new products.

In general, EMA has reported a reduction in overall positive opinions, with only 28 having been adopted as of July 2010. Companies have a lot of catching up to do if this number is to match the 117 mark reached in 2009, or even the 58 and 66 positive opinions that were adopted in 2007 and 2008, respectively.

The number of negative opinions is also down from eight in 2009 to just one so far in 2010. Although this may seem like a positive development, it seems to be part of a larger and more disturbing trend for a lack of marketing authorization applications as a whole. So far for 2010, only 40 new marketing authorisation applications have been filed. Again, this figure will change as the year goes on but if the pace continues throughout the second half of 2010 then the number will lag behind previous years. For 2007, 2008, and 2009, the total number of product applications started was 90, 103, and 95, respectively.

Looking solely at marketing authorization applications for new products, there is mixed news. The number of filed applications is already 20 for 2010, compared with 35 for the whole of 2009, which is a robust number considering the drying pipelines of many companies. For finalized applications, however, the difference between this and previous years is greater—only 11 have been finalized thus far compared with 40 and 49 for 2008 and 2009, respectively.

Overall, the total number of finalized marketing authorisation applications for all products is much lower than 2009, in which 125 applications were finalised. So far, only 30 applications have been finalized in 2010. In comparison, in 2007 and 2008, 65 and 72 marketing authorization applications were finalized, respectively. The sharp increase in finalized applications in 2009 could mainly be attributed to a huge rise in the number of applications for generic-drug products seen in 2008 (30 applications filed) and 2009 (38 applications filed), with 51 applications finalized in 2009.

There’s still five months of the year remaining before a full picture of marketing authorization application trends for the year presents itself. However, EMA has said it will be providing monthly updates on its website.