CSRXP APPLAUDS FDA APPROVAL OF SECOND INTERCHANGEABLE BIOSIMILAR FOR INSULIN

Interchangeable Biosimilars Help Provide Patients with Greater Choice and More Affordable Alternatives to High-Priced Brand Name Drugs

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 drug Rezvoglar, as a second alternative to brand name drug manufacturer Sanofi’s insulin product Lantus.

“CSRxP has been a longtime advocate for the role interchangeable biologics can play in helping to boost competition in the prescription drug marketplace and provide greater choice and more affordable alternatives for patients,” said CSRxP executive director Lauren Aronson. “The FDA’s decision to approve Rezvoglar is another encouraging step that will help make insulin products more affordable and crack down on brand name drug manufacturers’ egregious pricing practices, such as shadow pricing, that have led to this crisis of affordability.”

In October 2021, CSRxP applauded the FDA for approving Cyltezo as the first interchangeable biosimilar for low dose applications of brand name manufacturer AbbVie’s rheumatoid arthritis biologic, Humira.

In July 2021, CSRxP welcomed the FDA’s decision to approve the first interchangeable biosimilar drug, Semglee, as the first alternative to brand name manufacturer Sanofi’s insulin product, Lantus.

In May 2019, CSRxP praised the FDA for finalizing guidance on interchangeable biosimilars.

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 biosimilars. 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 Big Pharma’s egregious pricing practices that created a crisis of insulin affordability HERE.

Learn more about the importance of increased competition in the biologic marketplace and the cost of Big Pharma’s patent abuse on blockbuster biologic drugs HERE.

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