US approvals of biologicals doubled in last decade

Biosimilars/Research | Posted 10/06/2011 post-comment0 Post your comment

Regulatory approvals for new biological drugs in the US have nearly doubled in the last decade compared with the 1990s, according to the May/June 2011 issue of the Tufts Center for the Study of Drug Development (CSDD) Impact Report. However, the author of the report, Research Assistant Professor Janice Reichert, said there are still ‘substantial challenges’ to be faced by biologicals manufacturers if they wish to ‘maintain that pace’.


The FDA approved 65 new biopharmaceuticals between 2000 and 2009, a significant increase compared to the 1990s and 1980s, where, only 39 and 13 biologicals were approved, respectively. FDA approvals of recombinant protein products increased slightly from 54% in the 1980s to 57% in the 2000s. In addition, the study showed that approvals of new biologicals in the 2000s were more evenly distributed across therapeutic categories, compared to during the 1980s and 1990s.

Dr Reichert warned however that ‘biopharmaceutical development remains complex and developers face substantial challenges if they are to continue winning approvals at the pace of the last decade’. This is underscored by the fact that the average combined clinical and approval phase time for biologicals rose to 95 months during the 2000s, up from 77 months in the 1990s. This may put drug manufacturers under pressure to ‘further streamline the development process to assure greater consistency across compounds and within disease areas’.

Source: Tufts University

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