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# FDA Approves Mylan’s Semglee Insulin Glargine
- URL: https://www.fdaweb.com/fda-approves-mylans-semglee-insulin-glargine/
- Published: 2020-06-11T12:00:00.000Z
- Updated: 2026-09-14T16:17:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146983

FDA has approved Mylan’s Semglee (insulin glargine) indicated to improve glycemic control in adult and pediatric patients with Type 1 diabetes and in adults with Type 2 diabetes. Upon [approval](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210605&ref=fdaweb.com), the NDA was deemed to be an approved BLA and thus it can be a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product.