The US FDA has approved Eli Lilly’s Basaglar, a ‘follow-on’ of Sanofi’s $8bn-a-year basal insulin product Lantus.
Basaglar (insulin glargine) is the first insulin product to be approved via the truncated 505(b)(2) US regulatory pathway, according to the FDA, which said the new product would “expand the availability of treatment options for health care professionals and patients”.
The agency said the safety and efficacy of Basaglar were supported by two clinical studies involving 534 and 744 patients with type 1 and type 2 diabetes, respectively.
The Lantus ‘follow-on’ was awarded tentative approval by the FDA in August 2014 and has also been approved in Europe as Abasaglar and has been launched in 11 countries to date, including Germany, the UK, the Netherlands, Denmark and Japan.
The approval comes after settlement of a patent dispute between Lilly and Sanofi in September, in which Lilly agreed not to launch a pen injector version of insulin glargine – sold by Sanofi as Lantus SoloSTAR – until December 15 2016. The settlement did not cover insulin glargine sold in vials or combination products.
Basaglar is also delivered via a prefilled pen injector – the KwikPen – and Lilly confirmed that it will not be launching the product until the end of next year.
Approval is a boost to Lilly, which decided earlier this month to abandon development of another Lantus rival – insulin peglispro – after concluding data on a potential toxicity issue made the project too risky to pursue.
Lantus is the top-selling basal insulin in the world but competition from versions of the brand and newer treatments has already started to affect sales, which fell more than 7% to €4.9bn in the first nine months of the year.
The product experienced a 19% decline in the US on the back of a slowdown of basal insulin market growth, discounting and an increase in the proportion of sales made through federal channels such as Medicaid.
Sanofi is defending its franchise by trying to switch diabetics to treatment with Toujeo, a longer-acting version of insulin glargine which was approved in April.