Semglee now available for better blood sugar control in diabetes

Currently, the product will be supplied as 100 Units/mL of insulin glargine in 10mL multiple-dose vials and 3mL single-use prefilled pens.

Semglee, co-developed by Biocon Biologics and its partner Mylan, is a biosimilar to Sanofi's Lantus insulin glargine injection.

An insulin analog is an altered form of insulin, different from any occurring in nature, but still available to the human body for performing the same action as human insulin in terms of controlling blood glucose levels in diabetes. Through genetic engineering of the underlying DNA, the amino acid sequence of insulin can be changed to alter its ADME (absorption, distribution, metabolism, and excretion) characteristic.

Semglee, a longer-lasting insulin analog works on the principle that a small amount is immediately available for use, and the remainder is sequestered in subcutaneous tissue. As the glargine is used, small amounts of the precipitated material will move into solution in the bloodstream, and the basal level of insulin will be maintained up to 24 hours.

The latest approval of Semglee follows a positive result from 2 identical confirmatory studies - the INSTRIDE 1 and 2 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 multicenter, open-label, randomized, parallel-group trial consisted of 558 participants with type 1 diabetes observed for a period of 52-weeks. Similarly, INSTRIDE 2 was a 24-week study of 560 patients with type 2 diabetes (including insulin-naïve patients). The primary outcome measured was a change in HbA1c from Baseline to 24 Weeks.

Similar results were observed in both the trials, where Semglee was found to be non-inferior to that achieved with Lantus about the mean change in HbA1c.

To date, 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 the FDA through the Mylan-Biocon Biologics collaboration.

According to Dr. Thomas Blevins, M.D., lead investigator for the INSTRIDE clinical trials, "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 to its reference product Lantus, thus expanding access for millions of people within this important patient community." 

https://www.prnewswire.com/news-releases/mylan-and-biocon-biologics-announce-launch-of-semglee-insulin-glargine-injection-in-the-us-to-expand-access-for-patients-living-with-diabetes-301120824.html.