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This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
HUMALOG® (insulin lispro) 100 units/mL: Biosimilarity to Admelog® (insulin lispro) 100 units/mL
Admelog (insulin lispro) is not considered biosimilar to Humalog (insulin lispro) in the United States.
Sanofi-Aventis in 2017, received FDA approval for Admelog® (insulin lispro injection) 100 units/mL via an abbreviated pathway as a follow-on biologic. The Admelog new drug application allowed the FDA to consider the safety and efficacy of Humalog® (insulin lispro injection) 100 units/mL as the relied upon listed drug and two phase 2 clinical trials specific to Admelog. In March 2020, all insulins were transitioned from drugs to biologics and due to regulatory definitional differences, Admelog is not considered a biosimilar in the United States.
Lilly 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
FDA = Food and Drug Administration
Lilly = Eli Lilly and Company
Date of Last Review: July 29, 2020