Skip to Main Content
Skip Nav Destination

FDA approves interchangeable biosimilar insulin product :

September 1, 2021

The Food and Drug Administration (FDA) has approved the first interchangeable biosimilar insulin product indicated to improve glycemic control in pediatric and adult patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Insulin glargine-yfgn (Semglee) is biosimilar to and interchangeable with insulin glargine (Lantus), a long-acting insulin analog, according to the FDA.

A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product approved by the FDA (also called the reference product). A biosimilar must have the same safety and effectiveness as the reference product. The interchangeable product can be substituted for the reference product without the intervention of the prescriber.

The biosimilar insulin product provides an additional option for treating diabetes.

According to the FDA, insulin glargine-yfgn can be expected to produce the same clinical result as insulin glargine. In addition, safety risks and diminished efficacy are not greater when switching between insulin glargine-yfgn and insulin glargine compared to using only insulin glargine.

Insulin glargine-yfgn is available in 10-milliliter vials and 3-milliliter prefilled pens and is administered subcutaneously once daily. Dosing for either insulin product is based on the patient’s needs. Neither product is recommended for diabetic ketoacidosis.

According to the package label, the safety and effectiveness of the biosimilar to improve glycemic control in pediatric patients with type 1 diabetes mellitus has been established through “an adequate and well-controlled trial of another insulin glargine product in pediatric patients age 6 to 15 years with type 1 diabetes and additional data in adults with type 1 diabetes.”

The label also notes that in the pediatric clinical trial for the reference product, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to adults with type 1 diabetes.

Safety and effectiveness of insulin glargine-yfgn in patients under age 6 with type 1 diabetes and in pediatric patients with type 2 diabetes have not been established.

Close Modal

or Create an Account

Close Modal
Close Modal