Mylan, Biocon Biologics Announce Launch of Semglee in U.S.

Mylan and Biocon Biologics India announced the U.S. launch of Semglee™ (insulin glargine injection) in vial and pre-filled pen presentations, approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee, which received final approval from the U.S. Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi's Lantus® and is approved for the same indications.

"The availability of Semglee provides another quality treatment option for patients living with diabetes in the U.S. We rigorously compared Semglee (insulin glargine injection) to the reference insulin glargine in participants with Type 1 and 2 diabetes and found that Semglee yielded similar (non-inferior) glycemic results in both groups. The safety, including immunogenicity, was similar too. As a result, this insulin was approved by the FDA for the same indications as its reference product Lantus, thus expanding access for millions of people within this important patient community," Dr. Thomas Blevins, M.D., lead investigator for the INSTRIDE clinical trials, said.

"We are proud to be the first company, following the reference product, to receive FDA approval on and launch both the vial and pen presentations of an insulin glargine treatment with an identical amino acid sequence to Sanofi's Lantus®. Even more importantly, we are proud to make Semglee available to the more than 30 million Americans living with diabetes in the U.S.2, providing more treatment options and increasing access. While providing our product at the most competitive list price on the market is an important step toward ensuring that those who need insulin are able to access and afford it, we also know that there is still work to be done to ensure this access and affordability reaches patients at the pharmacy counter. We remain committed to work across the healthcare system to improve outcomes for all,” Mylan CEO Heather Bresch said.

The approval for Semglee was based on a comprehensive analytical, preclinical and clinical program (including the INSTRIDE studies) which confirmed the PK/PD, efficacy, safety profile and immunogenicity of Semglee as compared to Lantus in patients with type 1 and type 2 diabetes.

This launch follows favorable judgments on all remaining patent claims asserted by Sanofi against Mylan's insulin glargine products. Although Sanofi may seek certain appeals of those judgments, Mylan is confident they will not affect commercialization.

Sanofi's total IQVIA sales for the 12 months ending June 30, 2020 were approximately $1.64 billion for Lantus 100 Units/mL Vial and approximately $4.36 billion for Lantus SoloSTAR Pen.

Mylan and Biocon Biologic's insulin glargine has received regulatory approval in more than 45 countries around the world and is the third product approved by FDA through the Mylan-Biocon Biologics collaboration.

The INSTRIDE 1 and INSTRIDE 2 studies were randomized, confirmatory clinical trials designed to evaluate the efficacy and safety of Mylan's proposed insulin glargine, MYL-1501D, versus branded insulin glargine, Lantus. INSTRIDE 1 was a 52-week noninferiority study in 558 T1DM patients, while INSTRIDE 2 was a 24-week study in 560 T2DM (including insulin-naïve) patients. In both studies, patients were randomized to receive either once daily MYL-1501D or Lantus and the primary endpoint was change from baseline in HbA1c after 24 weeks. Secondary endpoints included glycemic endpoints like change from baseline in fasting plasma glucose and insulin dose, as well as safety endpoints like systemic reactions, device-related safety issues and immunogenicity. The safety, efficacy and immunogenicity data from these studies in T1DM and T2DM patients indicated that there were no differences in the Semglee and Lantus arms.