FDA tentatively oks Eli Lilly/Boehringer Ingelheim’s biosimilar insulin

 

The US Food and Drug Administration has granted tentative approval for the use of Eli Lilly/Boehringer Ingelheim’s biosimilar insulin Basaglar, for long-lasting control of blood sugar levels in patients with diabetes in between meals and during the night.

More specifically, the regulator has issued a green light for improving glycaemic control in adults with type II diabetes and in combination with mealtime insulin in adults and paediatric patients with type I forms of the condition.

Basaglar, a biosimilar of Sanofi’s blockbuster diabetes drug Lantus, has the same amino acid sequence as the currently marketed insulin glargine product, and was tentatively approved for use with KwikPen, a pre-filled dosing device, the firms said.

The product has been assigned a “tentative approval” because, while it has ticked all the regulatory boxes for approval, it remains the subject of a patent infringement suit filed by Sanofi, and therefore to an automatic stay of up to 30 months, unless the court finds in favour of Lilly earlier.

Nevertheless, the tentative approval for Basaglar “is another step toward providing an important option for people with diabetes in the US who need basal insulin treatment,” noted Enrique Conterno, president of Lilly Diabetes.

Across the pond, advisors to the European Medicines Agency gave their backing for the approval of the product, which is to be marketed as Abasria in the region, in June.