Pre-Market Development Times for Biologic Versus Small-Molecule Drugs

Using key patent filing dates to measure total development time, the authors found that biologic drugs did not spend significantly longer in development than small-molecule drugs before FDA approval—challenging the legislative rationale behind the 12-year exclusivity period granted to biologics under the BPCIA, which was justified in part by presumed longer development timelines. These findings have important policy implications for ongoing debates about biologic exclusivity periods in both domestic legislation and international trade agreements.