Eli Lilly and Boehringer Ingelheim’s insulin Basaglar has now been awarded full clearance by US regulators, following a tentative approval in 2014, offering the first “follow-on” insulin glargine product to treat diabetes.
Basaglar, which is considered a biosimilar of Sanofi’s blockbuster diabetes drug Lantus in the EU but not the US, has the same amino acid sequence as the currently marketed insulin glargine product.
The product was assigned a tentative approval for controlling high blood sugar in adults and children with type I diabetes and adults with type II diabetes because, while it ticked all the regulatory boxes for approval, it remained the subject of a patent infringement suit filed by Sanofi.
Sanofi and Lilly finally settled the US patent infringement lawsuit relating to Lantus SoloSTAR (insulin glargine) in September.
The once-daily injectable was approved by regulators in Europe in 2014, where it is marketed as Abasria, after clinical studies showed the product to have a comparable quality, safety and efficacy profile to Lantus.