Mylan, Biocon Biologics Launch Semglee In The U.S.

(RTTNews) - Mylan N.V. (MYL) and Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., on Monday, announced the U.S. launch of Semglee in vial and pre-filled pen presentations, approved to help control 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, the companies noted.

Semglee, which received final approval from the U.S. Food and Drug Administration or FDA, has an identical amino acid sequence to Sanofi's Lantus and is approved for the same indications.

In addition, Mylan has submitted to FDA all necessary documentation to request approval of Semglee as a biosimilar to Lantus under the 351(k) pathway and remains confident in seeking an interchangeability designation.

Semglee is available in vial and pen presentations at a 65% discounted list price, the lowest available for a long-acting insulin glargine on the market, Mylan said in a press release.