The U.S. Food and Drug Administration approved last Wednesday the diabetes drug Basaglar, which is Eli Lilly's cheaper version of Sanofi’s insulin treatment Lantus.
The insulin glargine drug is a long-acting, man-made human insulin therapy – the first approved insulin product under the FDA’s shortened review process anchored on its similarities to an existing drug.
Back in September, a settlement with Sanofi over patent issues concerning Basaglar, allowed Eli Lilly and its partner Boehringer Ingelheim to launch the drug in the United States in December next year. Tentative FDA approval of Basaglar was provided August last year.
Basaglar is aimed at controlling high blood sugar in pediatric and adult patients of type 1 diabetes and adult type 2 diabetes.
Dr. David Kendall, Lilly Diabetes’ vice president for Global Medical Affairs, highlighted their company’s introduction of the first commercial insulin in the world over nine decades ago.
“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,” he said.
This latest drug approval is the 11th for Basaglar in the world, which will be launched simultaneously in different countries this year. It will be known in Europe under the trade name Abasaglar, dubbed “follow-on” biologic instead of a biosimilar.
Lilly spokesperson Greg Kueterman said they have not determined a price for Basaglar yet, although noting that it will cost less than Lantus, which earned over $8 billion in sales in 2014. Rivaling pharmaceutical firms are on watch as the drug patent expires, seeking to launch more affordable versions.
About 21 million in the U.S. today suffer from diabetes, which over time can lead to serious health conditions such as blindness, heart disease, and kidney and nerve damage. Blood sugar control is administered to reduce the risk of some long-term consequences of the leading disease.
Basaglar doses are individualized, with the drug administered subcutaneously once every day at any time, but at the same time daily. It should not be taken for low blood sugar or by patients who are hypersensitive to insulin glargine or one of its components.
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