Biocon arm Biocon Biologics India and Mylan introduced Semglee (insulin glargine injection) in vial and pre-filled pens to help control high blood sugar in adult and pediatric patients with type 1 and 2 diabetes, in the U.S.
Semglee, which received final approval from the U.S. Food and Drug Administration (USFDA), has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications, as per a company statement.
“The availability of Semglee provides another treatment option for patients living with diabetes in the U.S. We rigorously compared Semglee 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,” said Dr. Thomas Blevins, M.D., lead investigator for the INSTRIDE clinical trials.
“The U.S. launch of Semglee takes us closer to realising our aspiration of reaching one in five insulin-dependent people with diabetes worldwide,” said Kiran Mazumdar-Shaw, executive chairperson, Biocon.
The company has been expanding affordable access to biosimilar insulins to patients in Japan, Australia, Europe, India and other emerging markets. In the U.S. They will offer Semglee at a wholesale price of $147.98 per package of five 3ml pens and $98.65 per 10ml vial, representing the lowest WAC (wholesale acquisition cost) for any long-acting insulin glargine after a list-price discount of 65%, as per a statement.
