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FDA Clears Insulin Glargine Product Basaglar for Diabetes Patients

First insulin treatment approved through abbreviated approval pathway

Basaglar (insulin glargine injection, Eli Lilly), a long-acting human insulin analog, has been cleared by the FDA to improve glycemic control in adult and pediatric patients with type-1 diabetes mellitus and in adults with type-2 diabetes mellitus.

Basaglar is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. Eli Lilly submitted an application for Basaglar that relied, in part, on the FDA’s finding of safety and effectiveness for Lantus (insulin glargine injection, Sanofi-Aventis) to support approval. The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify reliance, and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type-1 and type-2 diabetes mellitus, respectively. 

Basaglar is administered subcutaneously once daily at any time of day, but at the same time every day. Dosing should be individualized based on the patient’s needs. The product should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine or one of its ingredients.

Patients or caregivers should monitor blood glucose in all patients treated with insulin products. Insulin regimens should be modified cautiously and only under medical supervision. Basaglar may cause hypoglycemia, which can be life-threatening. Patients should be monitored more closely with changes in insulin dosage, coadministration of other glucose-lowering medications, meal pattern, and/or physical activity, and in patients with renal or hepatic impairment or unawareness of their hypoglycemia.

Severe, life-threatening, generalized allergic reactions, including anaphylaxis, or generalized skin reactions, angioedema, bronchospasm, hypotension and shock, may occur with the use of any insulin. The most common adverse events associated with Basaglar in clinical trials included hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema, and weight gain.

Basaglar received tentative approval from the FDA in August 2014 and has now been granted final approval. Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no “reference product” for a proposed biosimilar product.

Source: FDA; December 16, 2015.

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