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: Bioequivalency of Admelog (insulin lispro) to Insulin Lispro 100 units/mL

Admelog (insulin lispro) is not considered bioequivalent to Humalog (insulin lispro).

Detailed Information

Sanofi-Aventis received FDA approval for Admelog® (insulin lispro injection) 100 units/mL as a follow-on biologic. The Admelog new drug application 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.

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.

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 at 1-800-Lilly-Rx (1-800-545-5979).

Glossary

FDA = Food and Drug Administration

Lilly = Eli Lilly and Company

Date of Last Review: July 29, 2020


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