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Overall, last year can be considered quite a successful one in terms of new product approvals.
Overall, last year can be considered quite a successful one in terms of new product approvals. Nineteen products containing new biopharmaceutical molecular entities were approved in the United States and/or the European Union. These approval numbers are above average compared to the previous five years, which recorded a mean approval rate of 13 products. The 2013 annual approval rate was surpassed only in 2009, a year in which 20 new products came on the market.
Nineteen approvals, by any metric, is a healthy headline number. Digging a little deeper, however, reveals that just over two-thirds of these (a still credible 13 products) were genuinely new first time approvals. Six of the products, although newly approved in one region last year, had gained approval prior to that in the other region ).
Moreover, a significant difference in the absolute approval numbers was witnessed in the regions. A total of 16 approvals were recorded in Europe, while only five biopharmaceuticals came on the market in the US in that same period. This trend can partly be explained by Europe playing catch up in the case of some products; five of Europe’s 16 new approvals were already on the US market prior to 2013.
Those newly approved products that underpin particularly noteworthy technical, medical, or regulatory milestones are the focus a new Biopharm International article by Gary Walsh. Read it here.