Press release

American Diabetes Association® Applauds FDA for Addressing High Cost of Insulin by Making Insulin a Biologic

March 23, 2020 | Arlington, Virginia

Today, the U.S. Food & Drug Administration (FDA) officially moved insulin to the biologic regulatory framework. All insulins on the market have officially been deemed biologics by the FDA—paving the way for biosimilar and interchangeable insulins. Learn more about what this change means for people living with diabetes at

LaShawn McIver, MD, MPH, Senior Vice President of Government Affairs & Advocacy for the American Diabetes Association (ADA), issued the following statement:
"Insulin is life-sustaining for about seven million Americans—too many of whom can’t afford it and are forced to make hard choices that no one should have to make. As part of our investigation into the skyrocketing cost of insulin in 2018, the ADA released public policy recommendations that, if implemented, will help bring down the cost of insulin, including streamlining the biosimilar approval process. Transitioning insulin to the biologic process will allow for more competition from biosimilar or interchangeable manufacturers, which could drive down prices in the long-term. The fight for affordable insulin isn’t over yet, but we are excited to see positive momentum to address this crisis."

The ADA continues to be the driving force in federal and state efforts to ensure that insulin is affordable and accessible for all people who need it. Take action today at

If you are struggling to pay for insulin or know someone who is, the ADA has resources to help—visit

# # #


About the American Diabetes Association
Every day more than 4,000 people are newly diagnosed with diabetes in America. More than 122 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).