Competition for NDA Approval Begins Before “First-in-Class” Drugs Receive Market Approval

On November 3, 2015, Tufts Center for the Study of Drug Development (CSDD) published its November/December Tufts CSDD Impact Report. According to the report, when “first-in-class” drugs receive market approval a number of follow-on products are already well into the regulatory process.

The study analyzed 40 different classes of pharmaceutical products, including both drugs and biologics from 1998 – 2011 and found:

  • 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.

According to the report, the race for marketing approval among these products is increasingly competitive. Jopseph DiMasi, Ph.D., Director of Economic Analysis & Research Associate Professor at Tufts CSDD, noted that the development of first-in-class drugs oftentimes begins later than that of competitive drugs in the same class.

Study results show by the time first-in-class approval is granted, the “later-in-class” products are in the following stages of development:

1998 – 2011 2005 – 2011
Phase I 66% 90%
Phase II 60% 83%
Phase III 42% 57%


Half of all later-in-class products were approved within 2.7 years of first-in-class products that were approved between 1998 and 2011. That same timeframe was reduced to 2.3 years for first-in-class products approved between 2005 and 2011.

DiMasi’s bottom line is that drug development is a “competitive race.” This race occurs “before regulatory success for any drug in the class has been established.”

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