FDA Approves “Follow-On” Insulin for Diabetes

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FDA Approves "Follow-On" Insulin for Diabetes

On December 16, 2015, the U.S. Food and Drug Administration (FDA) approved the once-daily, basal (long-acting) insulin Basaglar (generic name insulin glargine injection) for controlling blood sugar in adults and children with Type 1 and Type 2 diabetes. The medicine, which is manufactured by pharmaceutical company Eli Lilly and Company, joins basal insulins Lantus (insulin glargine 100 U/ml), Levemir (insulin detemir), and Toujeo (insulin glargine 300 U/ml) on the U.S. market.

Basal, or background, insulin is typically taken once daily at any time of day (but at the same time each day) to cover the liver’s release of glucose into the bloodstream. Basaglar, which has the same amino acid sequence as Lantus and is known as a “follow-on” product (or a biosimilar in other countries), is the first insulin to be approved via an abbreviated process, in which the manufacturer demonstrated that the product is similar enough to Lantus to confirm it is safe and effective. Data specific to Basaglar from two clinical trials involving 534 people with Type 1 diabetes and 744 people with Type 2 diabetes were also submitted to the agency.


This medicine should not be used during episodes of hypoglycemia (low blood sugar) or in people who are sensitive to any of the ingredients. In clinical trials, the most common side effects of Basaglar were hypoglycemia, allergic reactions, injection site reactions, pitting of the skin at the injection site, itching, rash, fluid retention, and weight gain.

Basaglar is expected to be available in the United States starting on December 15, 2016 and will be delivered via the Basaglar KwikPen, a prefilled, disposable pen containing 300 units of the medicine.

For more information about Basaglar, see the press releases on the FDA and Eli Lilly websites. And to learn more about using long-acting insulin, read the article “Getting Down to Basals,” by 2014 Diabetes Educator of the Year Gary Scheiner.

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