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 Phase | 1998-2011 | 2005-2011 |
| Phase I | 66% | 90% |
| Phase II | 60% | 83% |
| Phase III | 42% | 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.