Lilly and Boehringer Ingelheim have had their biosimilar version of Sanofi’s blockbuster insulin Lantus accepted for review by European regulators.
The decision by the European Medicines Agency (EMA) moves the Lilly/ Boehringer insulin glargine biosimilar, known as LY2963016, one step closer to the market.
The investigational basal (long-acting) insulin for the treatment of both type 1 and type 2 diabetes is part of the two companies’ 2011 diabetes alliance and has been filed through the EMA’s biosimilar pathway.
Keen to stress the safety of their biosimilar candidate, Lilly and Boehringer said LY2963016 had been studied in “a comprehensive clinical development programme in order to meet the highest standards of safety, efficacy and quality”.
The partners have also carried out head-to-head phase III studies with Lantus, which last year grew its sales by 21 per cent to €1.34bn, in patients with type 1 and type 2 diabetes.
Gwen Krivi, VP, Lilly Diabetes product development, said: “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.
“We are pleased that the EMA’s acceptance of our application brings us closer to offering a new insulin glargine product to clinicians and their patients, coupled with the expertise they expect from Lilly and Boehringer Ingelheim.”
The companies are not the only firms working on biosimilar versions of big-selling insulins, the development of which is expected to play a major role in driving growth in the biosimilar market.
One of those firms is Mylan, which is collaborating with Biocon to develop and commercialise the Indian biotech firm’s versions of Lantus, Lilly’s Humalog and Novo Nordisk’s NovoLog.
Meanwhile, earlier this year Sanofi itself announced its own biosimilar portfolio, expected to include a version of Lantus, had moved into phase I development.
At the same time the France-based company, buoyed by rival Novo Nordisk’s failure to win US approval for its new insulin Tresiba, is planning to submit its Lantus successor U300 to regulators for approval next year.
Biosimilars are expected to be worth some $2.5bn this year and biosimilar insulins, along with biosimilar monoclonal antibodies, are expected to account for 57 per cent of the global biosimilars market by 2023.