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: Biosimilarity to Admelog® (insulin lispro) 100 units/mL

Admelog (insulin lispro) is not considered biosimilar to Humalog (insulin lispro) in the United States.

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Detailed Information

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.

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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