The drug helps in controlling 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.
To encourage broad patient access to this important medicine, Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five (5) 3ml pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market, said Biocon in a press release.
Eligible patients may also qualify for patient assistance and/or a co-pay card, similar to other medications in this class.
Additionally, Mylan has submitted to FDA all necessary documentation to request approval of Semglee as a biosimilar to Lantus.
“The commercialization of our insulin glargine in the U.S. represents another milestone achievement for Biocon in making insulin-based therapy increasingly accessible for people with diabetes globally. We are confident that along with our long-standing partner Mylan, we will be able to address the needs of millions of patients living with diabetes in the U.S. Leveraging our science and global scale manufacturing expertise, we have been expanding affordable access to biosimilar insulins to patients in Japan, Australia, Europe, India and key emerging markets. The U.S. launch of Semglee takes us closer to realizing our aspiration of reaching ‘one in five’ insulin dependent people with diabetes worldwide,” said Kiran Mazumdar-Shaw, executive chairperson, Biocon.