FDA Approves Generic Swap for Brand-Name Insulin

Last week, the U.S. Food and Drug Administration (FDA) approved the first interchangeable biosimilar insulin product to give people with diabetes a lower-cost, generic option to costly brand name insulin.

This new product, called Semglee, is designed to help improve glycemic control in adults and young patients with type 1 diabetes and in adults with type 2 diabetes. It can serve as a substitute for the popular—but pricey—long-acting insulin, Lantus.

The two are near copies in terms of their safety and effectiveness. The main difference is in the price. The cost of a month’s worth of supply of Semglee reportedly ranges from $150 to $190 without insurance. For Lantus, it's closer to $340 to $520. If their doctor approves a patient to make the switch, they could save hundreds of dollars a month..

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” acting FDA Commissioner Janet Woodcock, MD, said in a statement. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

Why Insulin Is Necessary

More than 34 million people in the United States are diagnosed with diabetes, a chronic health condition that impacts how the body stores and uses sugars for energy.

Whether or not a person with diabetes needs insulin depends on the type that they have and other factors. 

“With type 1 diabetes, you have an absolute lack of insulin,” diabetes researcher Paresh Dandona, MD, PhD, professor of medicine at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, tells Verywell.

People with type 1 diabetes need to take insulin daily to survive.

"The extra insulin is injected to compensate for lack of their own insulin," Jamie Alan, PharmD, PhD, associate professor of pharmacology and toxicology at Michigan State University, tells Verywell. "The insulin will work in places like the muscle to allow the tissue to take up glucose from the blood. This allows the muscle to use the glucose for energy and will lower blood glucose levels."

Some people with type 2 diabetes need to use insulin too, but not in all cases.

Generic Insulin Can Help People Afford Treatment

Insulin is expensive, and experts say that offering lower-cost options is necessary to make sure that people with diabetes can manage the condition and avoid health complications.

"Relative to the rest of the world, the U.S. charges a considerably higher amount for insulin," Alan says, pointing out there is "a really ‘closed’ market for insulins" that can lead to insulin manufacturers "price gouging."

Dandona says that this high cost means that "a lot of patients cannot afford insulin now." Making generic insulin available means that it "becomes a lot more affordable for people," Dandona adds.

However, even with a generic substitute, Dandona says that the cost of insulin in the U.S. is still higher than it should be, noting that some patients even go to Canada for their insulin because it costs “far, far less” there than it does in the U.S.

“Insulin, even with a generic label, can still remain relatively expensive," Dandona says. "That really bothers me.”

The hope for biosimilar insulin is that the product "will help patients to afford their medication," Alan says. That includes making sure that patients do not feel the need to “ration” their insulin to try to save money—a practice that puts them at risk for serious long-term health consequences.