Eli Lilly and Boehringer Ingelheim announced today that their insulin glargine injection product, Basaglar® (a follow-on biologic for Sanofi’s Lantus®), is now available by prescription in the U.S.

Although Basaglar is approved as a biosimilar for Lantus in Europe, in the U.S., Basaglar is not technically considered a biosimilar.  In the U.S., Lantus and other insulins are regulated under the Federal Food, Drug and Cosmetic Act like other drugs, and they are not treated specifically as biological products under the Public Health Service Act, so they cannot act as the reference product for a biosimilar.  Because of this, Lantus is licensed under an NDA, and Basaglar was approved through the 505(b)(2) regulatory pathway for follow-on drugs instead of the 351(k) pathway for biosimilars.

As we previously reported, CVS intends to replace Lantus with Basaglar on its standard formulary list beginning January 1, 2017.