Generic Drug Approvals Outpace New Prescription Medications in Europe
As reported in the March issue of Pharmaceutical Technology Europe, figures published by the European Medicines Agency (EMA) showed that the approval rate for new drugs (branded, generics, biosimilars and orphan) increased between 2007 and 2009; however most of the approvals were for generic drugs not new ones.
According to the published figures there were 58 new drug approvals in 2007, 66 in 2008 and 117 in 2009. However, the number of approvals for branded products decreased during this period; 35 in 2009 compared with 41 in 2008 and 59 in 2007. On the other hand, the approval rate for generics skyrocketed with more than 50 in 2009 as compared with 4 in 2008 and 5 in 2007.
Interestingly, biosimilar products didn’t fare as well as small molecule generic drugs with the number of applications and approvals decreasing during the period. For example, in 2007 10 new biosimilar applications were filed as compared with 3 in 2008 and 1 in 2009. Likewise, the number of approved biosimilar products decreased with 5 in 2007, 6 in 2008 and 0 in 2009. This trend suggests that biosimilars, mainly therapeutic proteins are not faring well in the European market. However, this is likely to change as patents begin to expire for monoclonal antibody-based drugs which are increasingly becoming the new drugs of choice for many indications including oncology, inflammation and metabolic diseases. Nevertheless, there is a growing emphasis and trend on developing generic medications as compared with new ones. Expect this trend to continue as patent expiry for many small and large molecule continues to draw near.
Until next time…
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