US drugmakers in competitive development races to be first to market, says Tufts CSDD

Nearly all later entrants to drug classes had begun clinical testing or were in regulatory review in the USA before the first drug within a pharmacologic class was approved, a newly completed analysis from the Tufts Center for the Study of Drug Development suggests.

For the 2005 - 2011 period, 90% of all first-in-class drugs had at least initiated Phase I clinical testing anywhere in the world or had filed an Investigational New Drug (IND) application with the US Food and Drug Administration before FDA approval for the first-in-class drug, according to Tufts CSDD.

"The bottom line is that development of drugs in pharmacologic classes is best characterized as a highly risky competitive race among manufacturers that occurs before regulatory success for any drug in the class has been established," said Joseph DiMasi, research associate professor and director of economic analysis at Tufts CSDD. He noted that development of the first-in-class drug often started later than competitive drugs in the same class.