First “follow-on” insulin glargine product approved to treat diabetes

FDA approved insulin glargine injection (Basaglar, Eli Lilly) to improve glycemic control in patients with diabetes mellitus.It is the first “follow-on” insulin glargine product approved to treat diabetes.

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Diabetes is the seventh leading cause of death in the United States, and according to the Centers for Disease Control and Prevention, approximately 21 million American have been diagnosed with the metabolic disease. Diabetes can cause serious health complications including heart disease, blindness, kidney failure and lower-extremity amputations.

Basaglar is a long-acting human insulin analog with an identical amino acid sequence to Lantus, another insulin glargine injection. Basaglar received tentative approval from FDA in 2014 and is not being granted final approval to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is delivered via the prefilled Basaglar KwikPen subcutaneously once daily at any time of day, but at the same time every day.

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“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 healthcare professionals and patients,” said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research.

This is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug and Cosmetic Act. The approval application demonstrated the Basaglar was sufficiently similar to Lantus and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The submission included results from pharmacokinetic and pharmacodynamics studies as well as Phase III studies in people with type 1 and type 2 diabetes mellitus comparing Basaglar to Lantus.

Basaglar may cause hypoglycemia and thus, patients should be monitored more closely with insulin dosage changes, co-administration of other glucose-lowering medications, meal pattern, and in patients with renal or hepatic impairment or hypoglycemia unawareness. Adverse events associated with the use of Basaglar in clinical trials included hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, edema, and weight gain.

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