CSRXP WELCOMES FDA APPROVAL OF FIRST INTERCHANGEABLE BIOLOGIC FOR INSULIN

Interchangeable Products Will Help Increase Prescription Drug Competition and Provide More Affordable Alternatives

Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) released a statement today in response to the Food and Drug Administration’s (FDA) decision to approve interchangeable biologic Semglee, as an alternative to brand name manufacturer Sanofi’s Lantus insulin product.

“CSRxP has been a longtime advocate for clearing barriers to investment in interchangeable biologics that can help boost competition in the prescription drug marketplace and provide more affordable alternatives for American patients,” said CSRxP executive director Lauren Aronson. “The approval of Semglee is a welcome and encouraging step in the right direction to make insulin products more affordable for every American who needs them, and break brand name manufacturers’ egregious shadow pricing tactics aimed at blocking competition and increasing prices.”

In May 2019, CSRxP praised the FDA for finalizing 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 in a statement at the time. “The FDA’s framework will allow interchangeable biologics to develop and enter the market more easily, providing patients with more choice and boosting competition.”

In 2018, CSRxP sent a letter, co-signed by more than a dozen health care organizations, to then-FDA Commissioner Scott Gottlieb urging the agency to finalize guidelines for interchangeable biologics. The letter stressed that providing a clear, consistent framework would encourage manufacturers to invest more in research and development of interchangeable products.

Learn more about additional market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.