FDA Will Act On BLAs Seeking Additional Indications Within Six Months

In a draft guidance published Thursday (Feb. 6), FDA says it hopes to nearly cut in half the amount of time it takes to review and act on biosimilar application supplements that seek approval for additional indications beyond those currently licensed. FDA’s original goal date was 10 months; that timeline has been reduced to six months. The guidance, “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed,” explains how...