FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products | FDA

FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products | FDA

FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

Transition is Expected to Increase Patient Access and Potentially Lower Prices on Insulin

Today, the U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March. Today’s actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients and health care providers.

On March 23, 2020, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulins and other biological products, will be deemed to be a license for the product under the Public Health Service (PHS) Act. This will, for the first time, enable submission of applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. As such, the transition of insulin products from approved drug applications to deemed biological product licenses will open up those products to potential biosimilar and interchangeable competition. The availability of approved biosimilar and interchangeable insulin products is expected to increase patient access, adding more choices and potentially reducing costs of insulin products.

“Biologic drugs are often complex therapies that can be used to treat some of the most serious illnesses, including autoimmune diseases, rare genetic disorders and diabetes. Life-sustaining insulin products are biologics, but to date, there has been limited competition in the marketplace, resulting in fewer choices and higher prices for patients. This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace,” said FDA Commissioner Stephen M. Hahn, M.D. “These critical therapies often carry a heavy price tag; the cost of insulin has risen over the past decade. Opening these products to increased competition is expected to ...