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:
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.”
November 5, 2015
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...
November 5, 2015
According to an infographic report from the California Life Sciences Association (CLSA), FDA approval times have decreased by nearly 50% since 2009. The infographic, entitled “Tracking FDA Drug...
November 5, 2015
In a recent post on the FDA Voice blog, the Agency reported that its generic drug program hit record highs in 2016. In the blog post, Kathleen “Cook” Uhl, M.D., Director of FDA’s Office of Generic...