FDA nod for first rapid-acting insulin biosimilar

The US Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart), from Denmark’s Novo Nordisk (NOV: N), for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.

The FDA granted approval of Merilog to a US subsidiary of French pharma major Sanofi (Euronext: SAN).

Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA, the agency noted. As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial.