Biopharmaceuticals accounted for 35% of all new drug approvals in the USA from 2006 through 2016, and a robust development pipeline suggests that the recent increased pace of biotech approvals will continue for the next decade, according to a newly completed assessment from the Tufts Center for the Study of Drug Development.
The annual pace of 13 new biotech products approvals by the US Food and Drug Administration during the study period accelerated to more than 20 per year during 2014-16, while 220 major pharmaceutical and biotechnology firms worldwide were conducting 429 Phase III trials for biopharmaceuticals at the end of 2016, Tufts CSDD found.
"Given the historically high,74% Phase III-to-approval success rate of biologicals in late stage development, and the extensive biotech product pipeline, the high pace of biotech product approvals will likely continue through the next decade," noted Ronald Evens, adjunct research professor at Tufts CSDD, who conducted the analysis.
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