The Food and Drug Administration (FDA) has approved Semglee® (insulin glargine-yfgn injection) as the first interchangeable biosimilar insulin product indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Semglee is a long-acting human insulin analogue that has an identical amino acid sequence to Lantus® (insulin glargine). The interchangeable biosimilar product may now be substituted for the reference product, Lantus, at the pharmacy counter and without the need for an intervention from the prescriber.
The approval was based on data from the INSTRIDE 1 (ClinicalTrials.gov Identifier: NCT02227862) and 2 (ClinicalTrials.gov Identifier: NCT02227875) confirmatory studies that evaluated the efficacy and safety of Semglee compared with Lantus in patients with type 1 and type 2 diabetes, respectively. INSTRIDE 1 was a 52-week noninferiority study in 558 patients with type 1 diabetes, while INSTRIDE 2 was a 24-week study in 560 patients with type 2 diabetes (including insulin-naïve patients).
Results from INSTRIDE 1 showed that treatment with Semglee was found to be noninferior to that achieved with Lantus with regard to the mean change in HbA1c over 24 weeks of treatment in adult patients with type 1 diabetes (difference from comparator, 0.03 [95% CI, -0.06-0.12]).
Similarly, noninferiorty with regard to the reduction in HbA1c over 24 weeks of treatment was established in the INSTRIDE 2 study among adult patients with type 2 diabetes administered Semglee in combination with oral antidiabetic drugs (difference from Lantus + oral antidiabetic medication, 0.05 [95% CI, -0.11-0.21)].
Semglee is supplied as 100 Units/mL of insulin glargine in 10mL multiple-dose vials and 3mL single-use prefilled pens.
“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of types 1 and 2 diabetes mellitus,” said Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”
- FDA approves first interchangeable biosimilar insulin product for treatment of diabetes. News release. US Food and Drug Administration. July 28, 2021. Accessed July 29, 2021. https://www.prnewswire.com/news-releases/fda-approves-first-interchangeable-biosimilar-insulin-product-for-treatment-of-diabetes-301343709.html.
- Viatris Inc. and Biocon Biologics receive historic approval for first interchangeable biosimilar Semglee® (insulin glargine-yfgn injection) for the treatment of diabetes. News release. Viatris Inc. July 28, 2021. Accessed July 29, 2021. https://www.prnewswire.com/news-releases/viatris-inc-and-biocon-biologics-receive-historic-approval-for-first-interchangeable-biosimilar-semglee-insulin-glargine-yfgn-injection-for-the-treatment-of-diabetes-301343915.html.