The Food and Drug Administration (FDA) has approved Semglee™ (insulin glargine injection; Mylan and Biocon) 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; Sanofi). It was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic.
The approval was based on data from the INSTRIDE 1 and 2 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)].
As for safety, the most common adverse reactions reported with Semglee included hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
“The global INSTRIDE clinical studies have demonstrated no difference in safety, efficacy and immunogenicity of Semglee in comparison to the reference product, Lantus, in type 1 and type 2 diabetes,” said Dr Christiane Hamacher, CEO & Managing Director, Biocon Biologics. “Our goal is to enable access to patients in need of insulins, and we are working towards creating a patient ecosystem that helps in lowering comorbidities and achieving overall cost savings for the healthcare systems.”
The product will be supplied as 100 Units/mL of insulin glargine in 10mL multiple-dose vials and 3mL single-use prefilled pens.
For more information visit mylan.com and biocon.com.