US regulators have agreed to review Eli Lilly/Boehringer Ingelheim's long-acting insulin LY2963016, a biosimilar of Sanofi's blockbuster diabetes treatment Lantus (insulin glargine).
The US Food and Drug Administration will assess the drug as a treatment for both type I and type II diabetes, following in the footsteps of regulators across the pond in Europe.
Lilly and Boehringer say they have studied LY2963016 "in a comprehensive development programme in order to meet the regulatory standards of clinical and nonclinical safety, efficacy and quality," and note that the filing also contains data from Phase III trials in which their treatment was pitted against Lantus.
Around 24.4 million Americans suffer from diabetes, and Gwen Krivi, head of Lilly Diabetes product development, previously said that long-acting insulin "is a mainstay treatment for many people with diabetes, and we anticipate that insulin glargine will continue to be widely used for many years to come".
Lantus is a top-earner for Sanofi's, pulling in sales of 1.45 billion euros in the third quarter of this year.