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The below information is provided in response to your request and may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above.
Sanofi-Aventis received FDA approval for Admelog® (insulin lispro injection) 100 units/mL on December 11, 2017 as a follow-on biologic. The Admelog new drug application was filed through the 505(b)(2) pathway, which allows the FDA to consider the safety and efficacy of Humalog® (insulin lispro injection) 100 units as the listed drug relied upon. Admelog is not considered a biosimilar in the United States because of differences in the regulatory submission pathway.
Eli Lilly and Company has not investigated Admelog. The best source of information for any product is its manufacturer. Therefore, please refer to Sanofi-Aventis for questions specific to Admelog.
Enclosed Prescribing Information
Humalog [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
Date of Last Review: December 01, 2017