Concentrated Human Insulin U-500: Pharmacology and Prospective Utilization

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Project Line:
Health Technology Review
Project Number:
HE0009-000
Final Biosimilar Summary Dossier Issued:

A concentrated solution (500 units/mL) of regular biosynthetic human insulin (U-500), marketed under the trade name Entuzity (Eli Lilly), was recently approved in Canada for adults and children with diabetes mellitus who require more than 200 units of insulin per day. The pharmacological properties (pharmacokinetics and pharmacodynamics) of this product may differ from the various U-100 insulins on the market. This project will review the data comparing the properties of these formulations and discuss clinical implications. It will also study the current utilization of U-100 across Canada and define the population using more than 200 units per day in order to predict the uptake of U-500 and the resulting cost to various public drug plans.