Posted by Michael Wonder on 25 Nov 2019
Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
25 November 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes.
If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness. And consistent, lifelong access to insulin is imperative to patient survival and quality of life. However, we are aware that the high cost of insulin raises serious concerns about the ability of many patients to access insulin products.
This is an issue the FDA takes very seriously; therefore, today we are announcing new draft guidance that is intended to help facilitate the development of, and improve patient access to, life-saving insulin products.
