The end of the year is just around the corner so I thought I’d spend some time today looking at how marketing authorisation applications are progressing at the European Medicines Agency. The past few years have witnessed some dreary numbers in both Europe and the US when it comes to new products, but the figures for 2011 could be early indicators for a 2012 upturn.
Statistics are currently available for January–September 2011. So far, the EMA has issued 74 positive opinions on marketing authorisation applications. Overall, the agency has started 76 marketing authorisation applications and finalised a further 79. So, what kind of picture do these statistics paint? Quite a bright one, actually, particularly in comparison to the bleakness of 2010 when the EMA issued only 51 positive opinions for marketing authorisation applications.
2011’s number of finalised marketing authorisation applications (79) has overtaken 2010’s low figure of 54; indeed, the year has also beaten 2008’s 72 finalised applications. However, there’s still a long way to go to outdo 2009’s 125 finalised applications, which were partly driven by a high number of applications (51) for generic products. This year, there has once again been a considerable number of marketing authorisation applications for generic products, with 28 finalised compared with only 20 in 2008.
There has also been a noticeable increase in the number of applications for new products, which is positive considering the amount of criticism that has been directed at the pharma industry’s innovative pipeline. So far, the agency has finalised 32 applications for new drugs compared with just 21 last year. New orphan medicinal products are also on the rise: 11 applications have already been finalised this year compared with six in 2010.
For started marketing authorisation applications, it’s a little different: 76 started applications in 2011 compared with 90 in 2010. Breaking down the numbers, however, the EMA starts roughly 8 applications per month, so the total could theoretically rise to 100 or more. We’ll have to wait until the end of the year to find out. Importantly, however, the number of started applications for new products is high at 36 applications compared with 2010’s 34.
There’s still a long way to go before anyone can safely say that the innovation drought is over, but given that the US has also seen greater drug approval rates this year compared with last, perhaps 2011 marks an important step towards this goal.