Humalog®

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: Bioequivalancy Admelog Insulin Lispro 100 units/mL

Admelog is not considered bioequivalent to Humalog.

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 bioequivalent to Humalog. In the absence of technology transfer, 2 biological products manufactured by different companies are not considered identical and thus are not deemed bioequivalent.

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.

It is important to talk to your health care provider if you are unsure about your current prescribed dose of insulin. He/she is in the best position to discuss your insulin dose as he/she has access to your medical records. If your health care provider has questions or needs additional information about Humalog, please have him/her contact Lilly.

Date of Last Review: December 01, 2017

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