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FDA Approves First Interchangeable Biosimilar Insulin

Insulin is an important part of therapy for many people who have diabetes. There are multiple types of insulins, and they are used in both the hospital and outpatient (home) settings to reduce blood sugar. Those who suffer from Type 1 Diabetes require insulin to control their blood sugars. For those with Type 2 Diabetes, there are other medications besides insulin (including oral options) available to help. Though, in many cases, insulin may also be required to control Type 2 Diabetes.

Read about How to Reduce Your Risks of Diabetes

There are rapid-acting, short-acting (regular), intermediate-acting, and long-acting types of insulins available for use. Long-acting insulin, also called basal insulin, lasts for 24 hours and helps keep blood sugars at bay for the entire day.  Rapid-, short-, and intermediate-acting insulins are usually used at mealtime to help reduce blood sugar after consuming food, which tends to spike blood sugars.

What is Insulin Glargine?

Insulin glargine is a long-acting insulin. Until recently, it has only been sold under the brand names Lantus®, Basaglar®, and Toujeo®. Toujeo® is a very potent version compared to the other brand names. It is difficult to make generic insulins because it is hard to copy this type of medication exactly. Insulins are biologic medications, which contain a large, complex molecule that has many slight variances, which makes it hard to duplicate.

In order to make a generic available, drug companies must make a biosimilar medication. Because the exact molecule used in the brand name products is unable to be copied, they make a very similar medication to use interchangeably. In order to have an interchangeable insulin approved by the FDA (Federal Drug Administration), the manufacturer must provide a very specific application and prove it will provide the same result for any given person without any additional risks or decrease in effectiveness.

Why it’s important to have generic availability

In July 2021, the FDA approved Semglee®, an insulin glargine biosimilar product. This product is available at a much lower cost than the equivalent brand name products. This is a game-changer for many who suffer from Diabetes, as the cost of insulin is often a big expense.

Unless your healthcare provider specifically indicates on your prescription that you require a brand name version of insulin glargine, it is possible that your pharmacy may automatically switch you to the cheaper alternative product, Semglee®. Feel free to ask your pharmacist if Semglee® is available to you and whether you can be switched per your provider’s prescription. In most states, the pharmacy is required to tell you whether you’re receiving an interchangeable biosimilar. If you’re not sure what you’re receiving, ask your pharmacist.

The cost of insulin is frequently an issue in the pharmaceutical world and often poses a burden to those people that require insulin to control their diabetes. The availability of Semglee® as a biosimilar insulin product is a huge step towards reducing the cost burden of those with diabetes.



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Dr. Andrea M. Jones

Dr. Andrea M. Jones is a clinical pharmacist specializing in transitions of care to facilitate a smooth transition for patients between the hospital and outpatient settings. Dr. Jones graduated from the University of Colorado School of Pharmacy and completed post-graduate year 1 residency at the Southern Arizona VA Healthcare System in Tucson, Arizona. Dr. Jones also worked in retail/community pharmacies for over 5 years during undergraduate studies at the University of Kentucky and pharmacy school at the University of Colorado.




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