Biosimilar Insulins for Type 2 Diabetes

Type 2 diabetes affects about 30 million people in the United States today. Biosimilar insulins may be an additional option for people with type 2 diabetes. They may be able to replace the more expensive biologic insulins that are often used to treat type 2 diabetes.^1,2

Biosimilar insulins are safe and effective. Like all drugs, they must be tested in clinical trials before they are approved by the US Food and Drug Administration (FDA).^2,3

What is a biosimilar?

Biosimilars are a type of biologic therapy. They are named for the fact that they are very similar to already-approved biologic drugs (reference products). Biologics may contain a combination of cell products, including sugars, nucleic acids, and a variety of different proteins. A biosimilar, due to the complexity of biologic drugs, only must be similar enough to an existing biologic drug that it is approved by the FDA for the same uses. You can think of a biosimilar drug as a “copycat” of its biologic reference product.^2,3

Like biologics, biosimilars are made from living cells in a lab. They contain proteins that mimic certain functions in human genes or cells. Biologic insulins also help keep a person’s glucose levels in a stable range. But biosimilars are often less expensive. This makes them a cost-saving option for many people.^2,3

The difference between a biologic and biosimilar

Biologics and biosimilars are not identical. But to be approved by the FDA, biosimilars must be just as safe and effective as their reference product. Biosimilars must work the same way with the same strength and dosage as their reference product. Biosimilars must also have no significant differences in purity and potency.^2,3

If a biosimilar meets all of these requirements and produces the same result as its reference product in clinical trials, it can be approved by the FDA.^2,3

The difference between a biosimilar and a generic

Biosimilars are not the same as generic drugs. The active ingredient in a generic drug has the same chemical structure as its reference drug. They are exact copies. Biosimilars are not exactly like their reference biologics.³

Like a generic, a biosimilar is usually cheaper than its reference medicine. In many states, pharmacists can switch out a generic medicine for its reference drug without telling the prescribing doctor to change the prescription. Some biosimilars have now been FDA-approved as “interchangeable,” meaning they can be switched out much like generics can be. Different states have different regulations around this process.^3,4

Biosimilar insulins and alternative reference drugs for diabetes

There are interchangeable biosimilar insulins for diabetes and then there are alternative reference drugs. Alternative reference drugs are not the same as biosimilars – they are simply different formulations of the same type of insulin.

Interchangeable biosimilars to Lantus® (insulin glargine):^5,6

• Semglee
• Rezvoglar
• Basaglar

Alternative reference drugs to Humalog® (insulin lispro):⁵

• Admelog
• Lyumjev

Alternative reference drugs to NovoLog®, NovoLog FlexPen®, NovoLog FlexTouch® (insulin aspart):⁵

• Fiasp

Other things to know

Not all approved biosimilars are available in the United States. While the FDA has approved many biosimilars, many are not yet available to consumers.^2,3

Biologics can be very expensive. A benefit of biosimilars is that they cost less than biologics. But it is not certain that they will cost you less out of pocket. Any potential savings will depend on your insurance company’s policies.^2,3,5

If you have type 2 diabetes and are interested in substituting your biologic insulin for its biosimilar insulin, talk with your doctor. They will discuss the pros and cons with you and address any questions you may have.²