FDA Approves Generic Swap for Brand-Name Insulin

Woman injecting insulin.

Javier Zayas Photography / Getty Images

Key Takeaways

  • The U.S. Food and Drug Administration approved Semglee, a biosimilar form of insulin.
  • As a generic, it can be automatically swapped for the price brand-name versions to help patients save money.
  • Doctors applaud the move, saying it addresses a major cost barrier for people with diabetes.

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..

What Is a Biosimilar Product?

A biosimilar product is not clinically different from a biological product that’s already been approved by the FDA. Patients can expect the same level of safety and effectiveness in a biosimilar product as would be found in the original product. It can be substituted for the original medication without a pharmacist needing to consult a doctor—similar to how generic drugs can be swapped for brand name versions. They are typically 15% to 35% less expensive than the original products they are being substituted for.

“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.

What This Means For You

If you need insulin to manage your diabetes, you might be able to save money by using a biosimilar product like Semglee. Ask your doctor if you can make the swap to generic insulin.

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.

3 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. U.S. Food and Drug Administration. FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes.

  2. U.S. Food and Drug Administration (FDA). Biological Product Definitions.

  3. Centers for Disease Control and Prevention (CDC). What Is Diabetes?.

By Korin Miller
Korin Miller is a health and lifestyle journalist who has been published in The Washington Post, Prevention, SELF, Women's Health, The Bump, and Yahoo, among other outlets.