The FDA July 28 approved Mylan's Semglee, the first interchangeable biosimilar insulin product approved in the U.S.
An interchangeable biosimilar product can be substituted for its reference product without a physician. Pharmacists can substitute the drug at a pharmacy, similar to the way generic drugs are substituted for brand-name drugs.
The reference product for Semglee is Lantus, a long-acting insulin made by Sanofi.
Semglee is designed to treat both adult and pediatric patients with Type 1 diabetes, as well as adults with Type 2 diabetes. More than 34 million people in the U.S. have been diagnosed with diabetes, according to the FDA.
"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, MD, said in a news release.
Biosimilar and interchangeable drugs have the potential to reduce costs, as they're cheaper than the original brand-name drug, similar to how generic drugs reduce costs.
Read the FDA's full news release here.