CSRxP Praises FDA For Finalizing Guidance On Interchangeable Biologics

May 10, 2019

Clearer Guidelines Will Increase Choice and Help Lower Prices

Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) today released a statement in response to the U.S. Food and Drug Administration (FDA) announcing finalized guidance on interchangeable biologics:

“This guidance marks great progress toward clearing barriers to investment in biologics that will help lower prescription drug prices and deliver relief for patients,” said CSRxP executive director Lauren Aronson.  “The FDA’s framework will allow interchangeable biologics to develop and enter the market more easily, providing patients with more choice and boosting competition.  We applaud Commissioner Sharpless for finalizing this important guidance.”

CSRxP sent a letter in 2018 to then-FDA Commissioner Scott Gottlieb urging the agency to finalize interchangeable biologic guidelines, stressing that a clear, consistent framework to demonstrate interchangeability would encourage manufacturers to invest in research and development of biologic products and seek designation of interchangeability for their products.