FDA Approvals of Biopharmaceuticals on the Rise

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, according to a new report from the Tufts Center for the Study of Drug Development, based in Boston. There are, however, substantial challenges ahead for biopharmaceutical manufacturers if they wish to maintain that pace, said Janice Reichert, PhD, research assistant professor at Tufts University and author of the study, in a press release about the report.

FDA approved 65 new biopharmaceuticals between 2000 and 2009, up from 39 approvals during the 1990s, and 13 in the 1980s. Of those new approvals overall, FDA approvals of recombinant protein products increased from 54% in the 1980s to 57% in the 2000s. In addition, the study showed that approvals of new biopharmaceuticals in the 2000s were more evenly distributed in six therapeutic categories, compared to those of the 1980s and 1990s.

At the same time, however, the average combined clinical and approval phase time for biopharmaceuticals rose to 95 months during the 2000s, up from 77 months in the 1990s. According to Reichert, that means drug manufacturers will need to “further streamline the development process to assure greater consistency across compounds and within disease areas.”