First-in-Class vs. Later Entrants Approval Analysis


Applied Clinical Trials

Nearly all later entrants to drug classes had begun clinical testing or were in regulatory review in the United States 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.

The analysis looked at 40 pharmacologic classes and included drugs and biologics between the 2005 - 2011 period, where 90% of all later-in-class drugs had at least initiated Phase I clinical testing anywhere in the world or had filed an investigational new drug application with the U.S. Food and Drug Administration (FDA) before FDA approval for the first-in-class drug, according to Tufts CSDD.

Key findings from the studies, reported in the November/December Tufts CSDD Impact Report, included the following:

  • 83% of all later-in-class drugs had at least initiated Phase II clinical testing abroad or in the U.S. prior to U.S. marketing approval for the first-in-class drug.

  • All later-in-class drugs had a patent filed somewhere in the world before the first-in-class drug was approved in the United States; 96% had a U.S. patent filed before first-in-class approval.

  • More than half of all later-in-class drugs received a 'priority rating' from the FDA.

Read the full release.


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