The US Food and Drug Administration has approved Merilog as a biosimilar of Novo Nordisk’s product Novolog (insulin aspart) for the improvement of glycaemic control in adults and paediatric patients with diabetes mellitus.
Merilog is the first rapid-acting insulin biosimilar approved by the FDA. Merilog (from Sanofi) helps lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3-ml single-use prefilled pen and a 10-ml multiple-dose vial.
Merilog is the third insulin biosimilar approved by the FDA; the two previous long-acting insulin biosimilars were approved in 2021.
A biosimilar is a biological product that’s highly similar to, and has no clinically meaningful differences from a biological product already approved by the FDA (reference product). Patients can expect the same safety and effectiveness from the biosimilar.
Till date, the FDA has approved 65 biosimilar products for various health conditions. Insulin, a hormone made by the pancreas, helps glucose enter the body’s cells to be used as energy. With diabetes, the pancreas doesn’t make enough insulin to keep blood sugar levels in the normal range, which could lead to serious health problems.
Like Novolog, Merilog is taken five to ten minutes before mealtime. It is injected under the skin on the stomach, buttocks, thighs or upper arms. Dosing of Merilog is adjusted according to individual patient’s needs.
Merilog may cause serious side effects, including hypoglycaemia (low blood sugar), severe allergic reactions and hypokalaemia (low potassium in blood). Other common side effects include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain, and swelling of hands and feet.
(Source: USFDA)