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The FDA approved as the first interchangeable biosimilar insulin product for diabetes, allowing for pharmacy-level substitution in states that allow it, the agency announced on Wednesday.

"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 healthcare costs," said Acting FDA Commissioner Janet Woodcock, MD, in a statement.

Semglee was first as a biosimilar to for adults and pediatric patients with type 1 diabetes and for adults with type 2 diabetes. This new approval deems Semglee as completely interchangeable with the reference product, Lantus, which was first approved in 2000. Evidence for Semglee's new interchangeable approval showed there to be no "clinically meaningful difference" between the biosimilar and reference product, in terms of safety, purity, and potency.

Semglee "can be expected to produce the same clinical result as Lantus" in any given patient, according to the FDA, and potential safety risks or risk of diminished efficacy when switching between the two products is no greater than staying on Lantus.

With this new approval, Semglee can be substituted out for Lantus by the pharmacy (otherwise known as "pharmacy-level substitution") without a prescriber intervening -- similar to with generic drugs. Biosimilar products can be used in patients who have been previously treated with the reference product, or those who have been newly prescribed the product.

This practice is able to specifically target healthcare costs, as biosimilar products often come at a reduced pricetag, about 15% to 25% lower than the reference products.

"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," said Woodcock.

However, only certain states allow pharmacy-level substitution. Because of this, the pharmacists check with their own state pharmacy board.

In a statement from the co-developers in August 2020, said Semglee is available "at a 65% discounted list price, the lowest available for a long-acting insulin glargine on the market."

Once-daily Semglee is administered subcutaneously and comes in both 10 mL vials and 3 mL prefilled pens.

Both insulin products are not recommended for treating diabetic ketoacidosis and some risks can include hypoglycemia, severe allergic reactions, hypokalemia, heart failure, and weight gain.

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