The US Food and Drug Administration has granted approval for Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with diabetes.
Basaglar 100 units/mL has an identical amino acid sequence to Lantus, another U-100 insulin glargine, and is delivered via the prefilled Basaglar KwikPen.
Go deeper with GlobalData
The drug has been developed as part of an alliance signed in January 2011 between Eli Lilly and Boehringer Ingelheim Pharmaceuticals (BIPI) to focus on compounds representing several of the largest diabetes treatment classes.
It is indicated that the drug should not be used to treat diabetic ketoacidosis, as well as during episodes of low blood sugar (hypoglycemia) or in people with an allergy to insulin glargine or any of the ingredients in Basaglar.
Lilly Diabetes Global Medical Affairs vice-president David Kendall said: "Lilly has a long history of developing and manufacturing insulin, having introduced the world’s first commercial insulin more than 90 years 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."
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataApproval is based in part upon an extensive clinical development programme.
The submission included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in people with type 1 and type 2 diabetes comparing the safety and efficacy of Basaglar to US and non-US-approved Lantus.
BIPI president and CEO Paul Fonteyne said: "The Basaglar FDA approval marks the first insulin therapy to be approved in the US as part of our alliance with Lilly and broadens our portfolio of treatment options for people with type 1 and type 2 diabetes.
"We remain committed to the care of people with diabetes and look forward to a successful US launch of Basaglar."
Basaglar received tentative approval from the FDA in August last year, and is now being granted final approval as a biosimilar product.
According to FDA, no insulin glargine products are currently licensed under the Public Health Service Act, so there is no reference product for a proposed biosimilar product.
