New biopharmaceuticals in the USA: trends in development and marketing approvals 1995-1999

The Tufts Center for the Study of Drug Development has collected data on the clinical and approval phases of the 26 new biopharmaceuticals approved by the US Food and Drug Administration between 1980 and 1999, Here, the data for biopharmaceuticals approved between 1995 and 1999 are presented grouped by product category, review status, orphan-drug designation and therapeutic indication, and the mean phase lengths are compared. They are also compared with the data for approvals during the periods 1982-1989, 1990-1994 and 1996-1998.