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Tufts CSDD Reports Significant Growth for New Biotech Products


A vigorous development pipeline predicts that the recent increased pace of biotech approvals will continue for the following decade, showing that biopharmaceuticals accounted for 35% of all new drug approvals in the U.S. from 2006-2016-according to a new assessment from the Tufts Center for the Study of Drug Development.

During the study period, Tufts CSDD found, the annual pace of 13 new biotech product approvals by the FDA accelerated to over 20 per year during 2014-2016, while 220 major pharma and biotechnology firms worldwide were conducting 429 Phase III trials for biopharmaceuticals at the end of 2016.

The following includes a list of key findings from the analysis, reported in the May/June Tufts CSDD Impact Report, which was released today.

  • The FDA approved 225 new biotech products during 2000-16, compared to 304 small-molecule drug approvals during the same time.

  • Biotech products in Phase III clinical trials spanned a broad range of molecules, with monoclonal antibodies accounting for 34.5% of the total.

  • Biotech products spanned a broad range of disease areas in Phase III trials at the end of 2016, with one-third focused on oncology.

  • Biosimilars accounted for more than 60 products in Phase III trials in 2016.







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