Semglee™ (insulin glargine injection; Mylan and Biocon Biologics) is now available to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.

The long-acting human insulin analogue has an identical amino acid sequence to Lantus® (insulin glargine; Sanofi) and was approved based on data from 2 confirmatory studies (INSTRIDE) that compared the efficacy and safety of Semglee to Lantus. “We rigorously compared Semglee to the reference insulin glargine in participants with type 1 and 2 diabetes and found that Semglee yielded similar (noninferior) glycemic results in both groups,” said Thomas Blevins, MD, lead investigator for the INSTRIDE clinical trials. “The safety, including immunogenicity, was similar too.”

Semglee is supplied in both vial and prefilled pen presentations.  The wholesale acquisition cost for a package of five 3mL pens is $147.98, while a 10mL multi-dose vial is $98.65. Additionally, a patient assistance program and co-pay card will be made available for eligible patients.

Changes in insulin regimen should be done under close medical supervision as it may affect glycemic control and predispose to hypoglycemia or hyperglycemia. 

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In an effort to obtain an interchangeability designation, Mylan is seeking approval of Semglee as a biosimilar to Lantus under the Food and Drug Administration’s 351(k) pathway.

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Mylan and Biocon Biologics announce launch of Semglee™ (insulin glargine injection) in the US to expand access for patients living with diabetes. Accessed August 31, 2020.