Eli Lilly and Sanofi have agreed terms in a patent dispute revolving around insulin glargine which will ward off the launch of a biosimilar to Sanofi’s Lantus brand until the end of next year.
The settlement relates to patents covering Sanofi’s Lantus SoloSTAR formulation of the basal insulin, a pen injector version which accounts for almost two-thirds of Lantus $7bn total sales. It does not cover insulin glargine sold in vials or combination products.
Under the terms of the agreement Lilly has agreed to pay royalties to Sanofi in exchange for a patent license from Sanofi, and has agreed to hold off on launching its own pen-based insulin glargine product Basaglar – partnered with Boehringer Ingelheim – until December 15, 2016.
Basaglar was granted tentative approval by the FDA last year but its launch was delayed by a legal challenge for Sanofi which alleged infringement of four patents on Lantus. The settlement in the US will also resolve other disputes around the world, according to Sanofi.
“The settlement agreement ends the legal dispute between Lilly and Sanofi and provides us with certainty as it relates to our US launch timing,” said Michael Harrington, senior vice president and general counsel for Lilly.
“This enables us to focus our efforts on preparing to successfully market and launch Basaglar in the US.”
Lilly and Boehringer have already started to roll out their biosimilar in Europe under the Abasaglar brand name, including in the UK, but delaying direct competition in the US will avoid a dramatic fall-off in Lantus sales for another 12 months. The US accounts for two-thirds of the product’s turnover.
Lantus is the top-selling basal insulin in the world but competition from biosimilars and newer brands has already started to affect sales, which fell more than 5% to €3.3bn in the first six months of the year.
Sanofi is defending its franchise by trying to switch patients to Toujeo, a longer-acting version of insulin glargine which was approved in April.