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.
Big Molecule Watch will continue to track FDA approvals related to biosimilars, so check back for further updates.