The FDA granted tentative approval to Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog for improving glycemic control in adults and children with diabetes.
The FDA concluded that Admelog met all necessary regulatory requirements for approval, pending any patent issues yet to be resolved, according to Sanofi.
The tentative approval is based on physicochemical, non-clinical and clinical similarity to Eli Lilly’s insulin lispro product, Humalog. Admelog is not being considered a biosimilar by the FDA. In the EU, Admelog received a positive opinion as a biosimilar in May.