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Report: Competition Quickly Follows First-In-Class Approvals

Posted 03 November 2015 | By Michael Mezher 

Report: Competition Quickly Follows First-In-Class Approvals

By the time "first-in-class" drugs receive marketing approval in the US, nearly all later iterations of those products have begun clinical testing or filed a new drug application with the US Food and Drug Administration (FDA), according to a new study by Tufts Center for the Study of Drug Development.

The study, which compared 40 drug classes with a first-in-class approval between 1998 and 2011, found that the race for marketing approval for new classes of drugs and biologics is increasingly competitive.

Status of 'Later-in-Class' Products at time of 'First-in-Class' Approval
Development Phase1998-20112005-2011
Phase I66%90%
Phase II60%83%
Phase III42%57%

The takeaway, according to Tufts researcher Joseph DiMasi, is that the "development of drugs [is] a highly risky and competitive race among manufacturers that occurs before regulatory success for any drug in the class."

And the development of first-in-class drugs often starts later than other drugs from the same class, he said.

Of the 40 drug classes the study examined, nearly half (48.5%) had three or more approved products on the market by 2014.

The authors also found that second entrants in a class of drugs have been able to reach the market quicker in recent years. From 1998-2011, half of all second entrants were approved just 2.7 years after the first-in-class product; however, from 2005-2011 that number dropped to 2.3 years.

Of the drug classes with a first-in-class approval from 2005-2011, nearly three-quarters (73%) had at least one competitor product in phase III trials when the first-in-class product was approved.

Sponsors of later-in-class products also frequently took advantage of programs at FDA to speed their products to market. The authors found that "more than half [51.5%] of all later-in-class drugs received a priority rating," and more than one-third (34%) received orphan designation.

Tufts Center for the Study of Drug Development


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