Basaglar is indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
It is considered as a biosimilar of Sanofi’s Lantus diabetes drug. Basaglar has the similar amino acid sequence as the currently marketed insulin glargine product.
Basaglar is designed to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes.
It should not be used for the treatment of diabetic ketoacidosis as well as during episodes of low blood sugar or in people with an allergy to insulin glargine or any of the ingredients in Basaglar.
Lilly Diabetes Global Medical Affairs vice president David Kendall: "Basaglar will be a welcome addition to our insulin and alliance portfolios, offering an option for people with diabetes who may need a long-acting insulin."
The agency issued tentative approval in August last year due to a then-pending patent dispute between Eli Lilly and Sanofi. The companies settled the US patent in September.
FDA center for drug evaluation and research director of the division of metabolism and endocrinology products Jean-Marc Guettier said: "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."
About 29 million Americans and an estimated 415 million people globally have type 1 or type 2 diabetes. Type 2 diabetes accounts for an estimated 90% to 95% of all diabetes cases.