Basaglar Gets FDA Nod in Diabetes

The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Basaglar (insulin glargine) is the first insulin product to be approved via the truncated 505(b)(2) USA regulatory pathway for biosimilars, according to the FDA, which said the new product would “expand the availability of treatment options for health care professionals and patients”.

Eli Lilly and Boehringer Ingelheim’s insulin Basaglar has now been awarded full clearance by USA regulators, following a tentative approval in 2014, offering the first “follow-on” insulin glargine product to treat diabetes. Eli Lilly’s application for the new drug demonstrated that it was sufficiently similar to another insulin glargine injection (Lantus-Sanofi Aventis) to justify trust in its effectiveness and safety.

Lilly opened the door to final approval when it negotiated a deal with Sanofi three months ago to put Basaglar on the market.

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. The pair began rolling Basaglar out in Europe this fall but, due to the slow process of convincing physicians to switch patients’ prescriptions, haven’t seen the rapid uptake commonly seen with generics.

The drug will be launched in the USA in December 2016, but before settlement has to be reached on the patent issues with Sanofi.

Sanofi AG’s Lantus earned more than $8 billion past year. The most common side effects reported in company trials included allergic reactions, injection site reactions, itching, rash and weight gain.

About 95 per cent of the estimated 29 million Americans with diabetes have Type 2 diabetes, which is often linked to obesity and a sedentary lifestyle.