EU generic applications down in 2010

August 20, 2010
Stephanie Sutton
Pharmaceutical Technology Europe

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalised this year to date.

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalised 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 product applications were started.

Despite many in the industry believing that generics are beginning to dominate with more products going off patent, the figures for 2010 show a different story. Generics clearly dominated 2009, but for 2010 they appear to be lagging markedly behind with only 9 generic product applications started versus 20 for new products. For finalised applications, generics and new products are about even so far with 12 for generics and 11 for new products.

In general, the 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 8 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 authorisation applications as a whole. So far for 2010, only 40 new marketing authorisation applications have been started. 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 authorisation applications for new products, there is mixed news. The number of started applications is already 20 for 2010, compared with 35 for the whole of 2009, which isn’t bad when you take into account the drying pipelines of many companies. For finalised applications, however, the story is much more depressing — only 11 have been finalised so far compared with 40 and 49 for 2008 and 2009, respectively.

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

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

www.ema.europa.eu