Marketing exclusivity periods for firstinclass drugs have fallen dramatically in recent decadesfrom a median of 10.2 years in the 1970s to 2.5 years in the early part of this decadeunderscoring 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 followon drugs fell even more rapidly from a median of 16.1 years in the 1960s to 1.1 years in the 200003 period.

“Since the early 1990s, nearly one in three followon drugs entered clinical testing earlier than did the firstinclass drug,” said Tufts CSDD Director of Economic Analysis and study author Joseph A. DiMasi, Ph.D., noting that “distinctions about innovativeness drawn between firstinclass and followon drugs may not be meaningful.”

He added that, contrary to widespread belief that development of followon drugssometimes called “metoo” drugsbegins after the first new drug in a therapeutic category receives marketing approval, development of nearly all followon drugs begins well before the firstinclass 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 onehalf of what turned out to be followon drugs had a U.S. or worldwide patent filed before the firstinclass drug had filed any such patents.

Since the early 1990s, 90% of followon drugs had initial pharmacologic testing and 87% were in clinical studies somewhere in the world prior to the firstinclass drug approval.

The average time for market entry between second and third followon 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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