June 11, 2020
The U.S. FDA has approved Semglee™ (insulin glargine injection), manufactured by Mylan and Biocon, to improve glycemic control in pediatric and adult patients who have type 1 diabetes mellitus, and in adult patients who have type 2 diabetes mellitus.
Diabetes is a metabolic condition in which the body cannot produce enough insulin or is unable to properly use the insulin it does produce. This leads to dangerously high blood sugar levels. Type 1 diabetes begins in childhood and is characterized by an inability to make insulin. Patients who have this form of diabetes must use an insulin product to treat the condition, which is fatal without insulin therapy. Type 2 diabetes occurs when the body is unable to properly use its own insulin. Over time, type 2 diabetes can also inhibit the body’s ability to make enough insulin. Not all patients with type 2 diabetes need insulin therapy. It is typically only required when other treatment approaches are no longer sufficient to control the patient’s blood sugar (glycemic control).
In clinical studies, Semglee was found to have no clinically meaningful differences when compared to Lantus®, a similar insulin glargine injection from Sanofi already approved by the FDA. One additional insulin glargine injection, Basaglar® (Eli Lilly and Boehringer Ingelheim) is also approved for use in the United States. While not automatically interchangeable with Lantus or Basaglar, Semglee may provide diabetes patients with an alternative treatment option.
Semglee is administered via subcutaneous injection in the abdominal area, thigh, buttocks, or upper arms at any time of the day, once every 24 hours. Dosing must be individualized based on the patient’s metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use.
Mylan and Biocon have not yet announced a launch date or pricing plans.