FDA approves Lilly’s Basaglar insulin analog

SILVER SPRING, Md. — The Food and Drug Administration announced Wednesday that it had approved Eli Lilly & Co.’s Basaglar (insulin glargine) injection. The drug is a long-acting insulin analog that can help adult and pediatric patients with type 1 and type 2 diabetes manage their blood sugar levels. 

 

Basaglar is the first drug approved by the FDA through its abbreviated approval pathway for what the agency calls “follow-on” products. To gain approval, Lilly demonstrated that Basaglar was similar enough to the insulin glargine injection Lantus. The agency said that this does not make Basaglar a biosimilar, as there is no reference product approved under the Public Health Service Act. Basaglar will be available in the U.S. after Dec. 15, 2016. 

 

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” said Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.