The FDA granted final approval of Sanofi’s 505(b)(2) application for Admelog yesterday. According to the FDA, Admelog is a follow-on product that, for approval, relied in part on FDA’s finding of safety and effectiveness of Eli Lilly’s Humalog and also relied on Admelog-specific data from two phase 3 clinical trials. The FDA had tentatively approved Admelog in September but withheld final approval until Sanofi and Eli Lilly resolved their patent dispute.
Admelog is the first short-acting insulin that the FDA has approved as a follow-on product. Sanofi reports that Admelog is indicated to improve control in blood sugar levels in adults and children age 3 or older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
In Europe, insulins are treated as biosimilars, and the EMA approved Admelog as a biosimilar in July 2017. According to Goodwin partner Scott Lassman, the FDA will likely follow suit and soon treat insulins as biosimilars.
Big Molecule Watch will continue to track FDA approvals related to biosimilars, so check back for further updates.