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Semglee FDA Approval History

Last updated by Judith Stewart, BPharm on July 28, 2021.

FDA Approved: Yes (First approved June 11, 2020)
Brand name: Semglee
Generic name: insulin glargine-yfgn
Dosage form: Injection
Company: Mylan Pharmaceuticals Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Semglee (insulin glargine-yfgn) is a long-acting human insulin analog biosimilar to Lantus (insulin glargine) indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus.

Development timeline for Semglee

Jul 28, 2021Approval FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
Jun 11, 2020Approval FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes

Further information

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