The US Food and Drug Administration has cleared Sanofi's Admelog, the first follow-on biologic version of Eli Lilly’s Humalog, to manage mealtime blood sugar levels in people with diabetes.
Admelog is a short-acting insulin approved on the back of a clinical development programme involving more than 1,000 adults living with type I or type II diabetes.
According to the Centers for Disease Control and Prevention, more than 30 million people in the US have diabetes.
“Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime," said Stefan Oelrich, executive vice president and head of Global Diabetes and Cardiovascular at Sanofi.
Also commenting on the approval, FDA commissioner Scott Gottlieb said: “One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease.
“In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.”
The drug was also granted marketing authorisation as a biosimilar, under the proprietary name, Insulin lispro Sanofi, by the European Commission in July.