Mylan and Biocon Announce U.S. Launch of Insulin Glargine Biosimilar

We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection).  Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market.  SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product.  SEMGLEE will be available in vials and pre-filled pens.  The lead investigator for clinical trials comparing LANTUS and SEMGLEE, Dr. Thomas Blevins, M.D., stated that SEMGLEE yielded similar results in terms of glycemic control and safety in participants with Type 1 and Type 2 diabetes mellitus.  SEMGLEE is approved by the FDA for the same indications as LANTUS, i.e., to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.