Marketing exclusivity periods for first-in-class drugs have fallen dramatically in recent decades -- from a median of 10.2 years in the 1970s to 2.5 years in the early part of this decade -- underscoring the competitive nature of drug development, a new study recently completed by the Tufts Center for the Study of Drug Development has found.
According to the study, the average time between first and second follow-on drugs fell even more rapidly -- from a median of 16.1 years in the 1960s to 1.1 years in the 2000-03 period.
"Since the early 1990s, nearly one in three follow-on drugs entered clinical testing earlier than did the first-in-class drug," said Tufts CSDD Director of Economic Analysis and study author Joseph A. DiMasi, Ph.D., noting that "distinctions about innovativeness drawn between first-in-class and follow-on drugs may not be meaningful."
He added that, contrary to widespread belief that development of follow-on drugs -- sometimes called "me-too" drugs -- begins after the first new drug in a therapeutic category receives marketing approval, development of nearly all follow-on drugs begins well before the first-in-class drug receives approval.
"New drug development remains a competitive race, and the first candidate to receive marketing approval to address a specific indication belongs to the sponsor that completes the development gauntlet first," DiMasi said.
The study, reported in the September/October Tufts CSDD Impact Report, released today, also found that:
-- Approximately one-half of what turned out to be follow-on drugs had a U.S. or worldwide patent filed before the first-in-class drug had filed any such patents. -- Since the early 1990s, 90% of follow-on drugs had initial pharmacologic testing and 87% were in clinical studies somewhere in the world prior to the first-in-class drug approval. -- The average time for market entry between second and third follow-on drugs also dropped significantly, from a median of 5.1 years in the 1960s to 1.3 years in the 1990s.
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