Sanofi and Eli Lilly agree terms which will enable biosimilar Basaglar to enter US market for diabetes after 15 December 2016
Sanofi announced that it has reached a settlement agreement with Eli Lilly and Company, which addresses patents on Sanofi's Lantus (insulin glargine) delivered via the SoloSTAR injection device. The agreement resolves a U.S. patent infringement lawsuit regarding Lilly's pursuit of regulatory approval for a biosimilar product Basaglar (Abasaglar in Europe) that would compete with Lantus. Sanofi and Lilly agreed to end that lawsuit and to discontinue similar disputes worldwide.
Under the agreement, Lilly will pay royalties to Sanofi in exchange for a license to certain Sanofi patents. In the USA, Lilly will not sell its biosimilar insulin glargine product before 15 December 2016. The agreement does not include Lantus (vial), Toujeo (formerly Optisulin) or combination products. The remaining settlement terms are confidential.
Comment: The effect of a US approval of Basaglar for use with the Kwik Pen (same as is used for Humalog) will be to bring a cheaper and long acting insulin to the market in late 2016 and will be felt by Tresiba (insulin degludec) from Novo Nordisk and Toujeo from Sanofi.
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