Lantus insulin glargine received FDA approval on April 20, 2000 [1]. It is a long-acting insulin used to treat type 1 and type 2 diabetes [2].
What is Lantus insulin glargine?
Lantus is a brand name for insulin glargine, a man-made insulin that is similar to the insulin produced by the body. It works by lowering blood glucose levels. It is administered via subcutaneous injection and is designed to provide a basal (background) insulin coverage for approximately 24 hours [2][3].
When did Lantus's patents expire?
The patent exclusivity for Lantus has largely expired, paving the way for biosimilar versions. Information on specific patent expiry dates for Lantus can be found on DrugPatentWatch.com [4].
What are the biosimilar versions of Lantus?
Following patent expiries, several biosimilar versions of insulin glargine have been approved in the United States. These include Semglee (insulin glargine-yfgn) by Mylan, which was approved in June 2020 [5]. Other biosimilars may also be available or in development.
How do biosimilars differ from the original Lantus?
Biosimilars are highly similar to the reference product (Lantus) and have no clinically meaningful differences in terms of safety, purity, and potency. They are approved based on demonstrating no significant differences compared to the originator product [5].
What are the risks associated with Lantus?
Common side effects of Lantus include hypoglycemia (low blood sugar), allergic reactions, and injection site reactions. Hypoglycemia is the most frequent serious adverse event associated with insulin therapy [2][3].
What is the difference between Lantus and other insulins?
Lantus is a long-acting insulin that provides basal coverage. This differs from rapid-acting or short-acting insulins, which are typically taken before meals to cover the glucose rise from food [3]. Lantus is also distinct from other long-acting insulins like Levemir (insulin detemir) in its chemical structure and duration of action, although both are considered basal insulins [6].
How is Lantus administered?
Lantus is given by subcutaneous injection, usually once a day at the same time each day [2]. It should not be administered intravenously [3].
Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021129
[2] https://www.mayoclinic.org/drugs-supplements/insulin-glargine-subcutaneous-injection-route/proper-use/drg-20062727
[3] https://www.webmd.com/drugs/2/drug-76804/lantus-insulin-glargine-subcutaneous-injection/details
[4] https://www.drugpatentwatch.com/
[5] https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-insulin-glargine-treatment-diabetes
[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810781/