FDA Approves First Biosimilar Insulin Product

The first interchangeable biosimilar insulin product has been approved by the U.S. Food and Drug Administration, providing patients with a cost-effective option for treating diabetes, the agency announced Wednesday.

Semglee (insulin glargine-yfgn), which is biosimilar to and interchangeable with Lantus (insulin glargine), was approved for use in adults and children with type 1 diabetes and adults with type 2 diabetes. Semglee, as all interchangeable biosimilar products, may be substituted for Lantus without prescriber intervention through "pharmacy-level substitution."

Semglee is offered in 10-mL vials and 3-mL prefilled pens and is administered subcutaneously once per day. In an August 2020 press release, the manufacturer said it was offering Semglee at a wholesale acquisition cost of $147.98 per package of five 3-mL pens and $98.65 per 10-mL vial, which it claims is the lowest wholesale acquisition cost for any long-acting insulin glargine on the market. The list price of a Semglee pen is estimated to be equivalent to the Lantus launch price in 2007, while the vial is listed at the 2010 Lantus price.

The approval of Semglee as a biosimilar to and interchangeable with Lantus was based on evidence showing the products are "highly similar" and do not have clinically meaningful differences in terms of safety, purity, and potency. Data showed that Semglee "can be expected to produce the same clinical result as Lantus (insulin glargine) in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) [are] not greater than the risk of using Lantus (insulin glargine) without switching," the FDA wrote in a press release.

The agency notes that dosing of Semglee should be based on individual patient needs and should not be used during episodes of hypoglycemia. Potential serious side effects with Semglee include hypoglycemia, severe allergic reactions, hypokalemia, and heart failure. The most commonly reported side effects include edema, lipodystrophy, weight gain, and allergic reactions.

Approval was granted to Mylan Pharmaceuticals.