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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.
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. In the absence of technology transfer, 2 biological products manufactured by different companies are not considered identical and thus are not deemed bioequivalent (Davies, 2017).
“Bioequivalent” is a pharmacokinetic term used to describe 2 medicinal products that release the same active substance into the body
at the same rate
to the same extent, and
under similar conditions (European Medicines Agency, 2017).
Two medicinal products are considered bioequivalent if
they contain the same active ingredient
they are pharmaceutically equivalent, and
their bioavailabilities, such as the rate and extent of absorption, after administration in the same molar dose lie within acceptable predefined limits (Committee for Medicinal Products for Human Use, 2010).
The bioequivalent criteria ensure comparable in vivo performance such as similarity in terms of efficacy and safety (Committee for Medicinal Products for Human Use, 2010).
In bioequivalence studies, the area under the plasma concentration curve and maximum plasma concentration of products are analyzed. For these parameters, the 90% CI for the ratio of the test and reference products should lie within the acceptance range of 80% to 125% (U.S. Department of Health and Human Services, 2017).
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
The published reference below is available by contacting 1‑800-LillyRx (1-800-545-5979).
Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency. Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf. Adopted January 20, 2010. Accessed June 22, 2017.
European Medicines Agency. Biosimilars in the EU: information guide for healthcare professionals. http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf. Updated April 27, 2017. Accessed June 22, 2017.
Humalog [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Considerations in demonstrating interchangeability with a reference product: guidance for industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Published January 12, 2017. Accessed June 22, 2017.
Date of Last Review: December 01, 2017