INDIANAPOLIS and RIDGEFIELD, Conn. — Eli Lilly and Co. and Boehringer Ingelheim Pharmaceuticals Inc. have received approval for Basaglar long-acting insulin (insulin glargine injection, 100 units/ml) in the United States.

Basaglar KwikPen

The companies said Basaglar has an identical amino acid sequence to Lantus, another U-100 insulin glargine, and is delivered via the prefilled Basaglar KwikPen.

Basaglar is indicated to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes.

“Lilly has a long history of developing and manufacturing insulin, having introduced the world’s first commercial insulin more than 90 years ago,” stated David Kendall, vice president of global medical affairs for Lilly Diabetes. “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.”

The Food and Drug Administration approval of Basaglar follows the medicaion’s tentative U.S. approval in August 2014, which was contingent upon patent litigation resolution. As per the settlement agreement with Sanofi, Basaglar is slated to become available in the U.S. starting on Dec. 15, 2016.

“The Basaglar FDA approval marks the first insulin therapy to be approved in the U.S. as part of our alliance with Lilly and broadens our portfolio of treatment options for people with type 1 and type 2 diabetes,” according to Paul Fonteyne, president and chief executive officer of Boehringer Ingelheim Pharmaceuticals. “We remain committed to the care of people with diabetes and look forward to a successful U.S. launch of Basaglar.”

This latest regulatory approval is the 11th for Basaglar worldwide, the companies said, with launches taking place in several countries this year, including under the trade name Abasaglar in Europe.