The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to NovoLog, marking a significant milestone as the first rapid-acting insulin biosimilar. Designed for both adult and pediatric patients with diabetes mellitus, Merilog offers clinicians an additional option for effective glycemic control.
Administered subcutaneously 5 to 10 minutes before meals, the product is available as a 3 mL single-use prefilled pen and a 10 mL multi-dose vial, providing flexible dosing tailored to individual metabolic needs.
The approval is backed by a phase 3 trial of 597 patients with type 1 and type 2 diabetes who received multiple shots daily. At week 26, blood sugar levels were similar for those who received the biosimilar and those on the reference product, confirming Merilog’s non-inferiority.
“Today’s approval highlights our continued efforts to improve the efficiency of the biosimilar approval process to help support a competitive marketplace and increase options for costly treatments, like insulin,” stated Peter Stein, M.D., director of the FDA’s Office of New Drugs.
The International Diabetes Federation predicts that by 2045, 1 in 8 adults, approximately 783 million, will be living with diabetes, an increase of 46%. More than 90% have type 2 diabetes. This development is expected to reinvigorate the insulin market amid ongoing debates over pricing and access. The introduction of Merilog underscores the FDA’s commitment to expanding high-quality treatment alternatives for millions of patients, while encouraging a more competitive pricing landscape in the diabetes care sector.
