FDA Makes Semglee the First Interchangeable Biosimilar

FDA Makes Semglee the First Interchangeable Biosimilar

July 28, 2021 – Mylan's Semglee^® (insulin glargine-yfgn) injection has been FDA approved as the first automatically interchangeable insulin and the first automatically interchangeable biosimilar. This allows pharmacists to dispense Semglee as a substitute for its reference product, Lantus^® (insulin glargine – Sanofi), without a new prescription. All other biosimilar products currently on the U.S. market require a new prescription if a patient would like it to be dispensed instead of the prescribed reference product.

Diabetes is a condition in which the body’s blood sugar can rise to dangerous levels. For many patients diagnosed with the disease, insulin is a necessary component of controlling their blood sugar. Poorly controlled diabetes can lead to numerous complications, including kidney disease, heart disease, blindness, nerve damage, hearing damage, and potentially fatal diabetic coma.

Originally granted FDA approval in June 2020, Semglee is a long-acting human insulin analog indicated to improve glycemic control in adults and children diagnosed with type 1 diabetes mellitus and in adults who have type 2 diabetes mellitus. Recommended dosing is based on individual patient factors such as metabolic needs, blood glucose (sugar) monitoring, glycemic control, type of diabetes, and prior insulin use. The patient or a caregiver can administer Semglee at home via subcutaneous injection once daily at the same time every day.

Semglee may offer some patients a more affordable treatment option, with a wholesale acquisition cost (WAC), or list price, of $98.65 per vial. Lantus currently has a list price of $283.56 per vial.