Image of Janet Woodcock, M.D., FDA acting commissioner

The U.S. Food and Drug Administration has approved the first biosimilar form of insulin for adults with diabetes type 2, and adults and pediatric patients with diabetes type 1. 

Semglee (insulin glargine-yfgn) is a safe and more cost-effective substitute for the drug Lantus (insulin glargine) in any given patient, FDA said in a Wednesday announcement. In clinical trials, Semglee improved blood sugar control as well as Lantus, and study participants who switched between the two drugs did so with no ill effects, the agency reported.

Biosimilars are made as alternatives to drugs like insulin that have living organisms as a key ingredient. Like generic drugs, they cost less than the brand-name medications they are modeled after. In the United States, biosimilars typically are marketed with initial list prices 15% to 35% lower than the list prices of brand name reference products, FDA noted. 

“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,” Acting FDA Commissioner Janet Woodcock, M.D., said. 

Semglee does not need a prescriber’s input to be substituted at the pharmacy, subject to state pharmacy laws. It will be offered in 10 mL vials and 3 mL prefilled pens for once-daily injection. Dosing of the drug, like Lantus, “should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia,” FDA said.

The FDA also has released materials for healthcare providers that explain biosimilars and interchangeable drugs.