Biologics and Biosimilars

Biography

Biography: Aruna Dontabhaktuni

Abstract

What does it take to qualify for the expedited FDA Drug approval? What is the breakthrough therapy designation application and how is it impacting the global drug development? In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA, of medications with the potential to provide the substantial improvement over existing treatments. “Breakthrough Therapy designation” is improved to hasten the growth and evaluation that are meant to treat the serious condition and introductory clinical proof indicates that the drug may reveal considerable increment over an available therapy on a clinically significant endpoint. To control whether the advancement over available therapy is considerable is a matter of discernment and depends on both the magnitude of the treatment effect, which could include the duration of effect and the elevation of an observed clinical outcome. In general, the primary clinical proof should show a clear advantage over available therapy. How the recent trends in globalization and the complexity of drug development have resulted in the possibility that expedited programs in one country may now influence drug development in another.