September 27, 2020

Biocon Biologics launches Semglee, drug to manage excessive blood sugar, in US



BENGALURU: Biocon Biologics, a subsidiary of Biocon, and Mylan have launched Semglee (insulin glargine injection) in vial and pre-filled pen shows within the US.

The drug helps in controlling excessive blood sugar in grownup and pediatric sufferers with sort 1 diabetes and adults with sort 2 diabetes.

It isn’t beneficial for the remedy of diabetic ketoacidosis.

Semglee, which obtained remaining approval from the U.S. Meals and Drug Administration (USFDA), has an similar amino acid sequence to Sanofi’s Lantus and is permitted for a similar indications.

To encourage broad affected person entry to this vital medication, Mylan is providing Semglee at a wholesale acquisition value (WAC)[1] of $147.98 per package deal of 5 (5) 3ml pens and $98.65 per 10ml vial, representing the bottom WAC for any long-acting insulin glargine in the marketplace, stated Biocon in a press launch.

Eligible sufferers might also qualify for affected person help and/or a co-pay card, much like different drugs on this class.

Moreover, Mylan has submitted to FDA all needed documentation to request approval of Semglee as a biosimilar to Lantus.

“The commercialization of our insulin glargine within the U.S. represents one other milestone achievement for Biocon in making insulin-based remedy more and more accessible for folks with diabetes globally. We’re assured that together with our long-standing companion Mylan, we can deal with the wants of hundreds of thousands of sufferers residing with diabetes within the U.S. Leveraging our science and international scale manufacturing experience, now we have been increasing reasonably priced entry to biosimilar insulins to sufferers in Japan, Australia, Europe, India and key rising markets. The U.S. launch of Semglee takes us nearer to realizing our aspiration of reaching ‘one in 5’ insulin dependent folks with diabetes worldwide,” stated Kiran Mazumdar-Shaw, govt chairperson, Biocon.