Basaglar (insulin glargine injection) by Lilly and Boehringer
The FDA has granted tentative approval for Basaglar (insulin glargine injection), a basal insulin. Basaglar is Eli Lilly and Co. and Boehringer Ingelheim"s basal insulin. Basaglar has the same amino acid sequence as the currently marketed insulin glargine product. While the FDA has determined that Basaglar meets the regulatory requirements for approval, it is subject to an automatic stay of up to 30 months due to litigation filed by Sanofi, which claimed patent infringement. Due to the Drug Price Competition and Patent Term Restoration Act, the agency cannot grant final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly before such time.