may, 2015

18may12:00 pm2:00 pmQED: Robert Lionberger, FDA. “Therapeutic Equivalence: The Key Issue for Generic Drug Review”


Event Details

This event is jointly hosted by QB3 and UCSF-Stanford CERSI. Lunch will be provided during the seminar from noon to 1:00 pm. An hour following is scheduled for informal Q&A with the speaker.

At least 84% of US prescriptions are dispensed as generic drugs. At FDA the regulatory processes that oversee this critical part of the health care system are being transformed by a new user fee program: the 2012 Generic Drug User Fee Amendments or GDUFA. The implementation of GDUFA has changed how generic drugs are reviewed at FDA bringing new review timelines and providing new ways for the generic industry to interact with FDA. I will explain the key parts of the generic drug review process and how it differs from the review of new or brand drugs. At the heart of the generic drug program is the concept of therapeutic equivalence, the idea that generic drugs should be able to be freely substituted for the original brand product or other generics. FDA’s conclusion about therapeutic equivalence are based on pharmaceutical equivalence and bioequivalence, but also are impacted by how patients interact and react to drug products.


(Monday) 12:00 pm - 2:00 pm


Mission Hall