A study published by the Tufts Center for the Study of Drug Development found that the streamlined 505(b)(2) approval process for new drug applications in the U.S. has not led to shorter approval times.
The 505(b)(2) pathway allows drug developers to seek FDA approval using safety and effectiveness data that was previously collected for a reference drug.
“While the 505(b)(2) regulatory pathway has been highly successful in bringing new therapies to market from 2009 through 2015, drug products approved under this pathway had a longer average approval time compared to new molecular entities approved during the same period,” director of economic analysis and principal investigator Joseph DiMasi said in prepared remarks.
The approval process with the FDA was designed to help companies avoid unnecessarily duplicating studies performed on a previously-approved drug.
“Our findings suggest that drug developers should not anticipate a 505(b)(2) application will necessarily result in a shorter approval time or limited FDA requirements,” DiMasi said. “As with any drug development program, it’s important to engage proactively with the FDA to better understand the data needed to bridge a 505(b)(2) program with the approved reference product.”
The researchers analyzed 451 original new drug applications approved by the FDA between 2009 and 2015. They found that 63% of those applications underwent the 505(b)(2) pathway and the mean approval time for those applications was almost 5 months longer compared to new molecular entities.
They also found that the streamlined applications received fewer expedited review designations that new molecular entities and the percentage of 505(b)(2) drugs approved on the 1st review cycle was lower than for all new molecular entities.