Lower-cost insulin now available through Express Scripts® Pharmacy
Semglee® is the first interchangeable biosimilar in the U.S.
The U.S. Food and Drug Administration (FDA) approved the first interchangeable biosimilar for insulin at the end of July 2021, and it’s exciting news for both adults and kids with diabetes.
Semglee is used to control blood sugar in adults and children with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The FDA originally approved Semglee as a biosimilar for Lantus®, a long-acting insulin injection, in June 2020. But the recent approval makes Semglee interchangeable with Lantus. This means a pharmacy can substitute Semglee for Lantus without needing to go back to the prescriber, depending on state pharmacy laws. Almost all states allow for this.
How will this help people who use insulin?
The main benefit people will see is cost savings, according to Robert Sardon, a pharmacist with Express Scripts® Pharmacy’s Therapeutic Resource Center for Diabetes. Biosimilars in the U.S. typically have launched with initial list prices 15% to 35% lower than the original product’s list price.
“The list price for Semglee is lower than the list price for Lantus,” Sardon said. “This should result in lower costs for patients and for health plans.”
Sardon said consumers can look at it as being similar to automatically substituting generics for brand-name drugs.
Having an interchangeable biosimilar product also makes things more efficient and saves everyone time. Many pharmacists no longer have to get pre-approval from prescribers to have Lantus prescriptions changed to Semglee, depending on the state the prescriber resides in and how the prescription is written.
Is Semglee a generic medication?
Not exactly, according to Sardon. Biologics, like Lantus and Semglee, are made from living sources, such as bacteria and yeast. That makes them different from conventional medications, which are commonly made from chemicals.
When the FDA approves an original biologic, like Lantus, that becomes known as the reference product. A biosimilar, like Semglee, is made with the same type of living organisms and has the same clinical characteristics as a reference product.
“Although the biosimilar must have the same strength, dosage, and treatment benefits as the reference product, it is not considered a true generic because of the slight variations from batch to batch,” Sardon said.
How do I know Semglee is safe and works?
As the first interchangeable biosimilar approved by the FDA, Semglee had to follow a rigorous three-step process:
First, the pharmaceutical manufacturer had to show that it’s biosimilar to Lantus — meaning highly similar with no clinically meaningful differences between safety, purity, and potency.
Next, they had to show that it works the same as Lantus and has the same results in any patient.
The final step was to show that switching between the two products doesn’t increase safety risks or decrease effectiveness. This was done through a switching study, in which patients alternate between the two products multiple times over a specific period of time.
The FDA will continue to monitor the safety and effectiveness of Semglee over time, just as it does with all medications.
Talk to your pharmacist about any new medications
If you have any questions about whether this medication (or any medication) is right for you or your loved ones, please reach out to your prescriber or pharmacist. Our Express Scripts® Pharmacy pharmacists are available 24/7 to answer questions and give you peace of mind.
Posted date: November 12, 2021
Updated: August 2, 2022