The US Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for the improvement of glycaemic control in adults and paediatric patients with diabetes mellitus, it said.
Merilog, a rapid-acting human insulin analogue, is the first rapid-acting insulin biosimilar product approved by the agency. It helps to lower mealtime blood sugar spikes to improve control of blood sugar in diabetics, and the approval is for both a 3 millilitre (mL) single-patient-use prefilled pen and a 10 millilitre (mL) multiple-dose vial.
It is the third insulin biosimilar product approved by the FDA, with two earlier products approved in 2021.
A biosimilar is a biological product highly similar to, and with no clinically meaningful differences from, one already approved by the FDA (also called the reference product). Patients can expect the same safety and effectiveness from the biosimilar as from the reference product. To date, the FDA has approved 65 biosimilar products for various health conditions.
Like Novolog, Merilog should be administered within five to 10 minutes before the start of a meal. It is administered subcutaneously by injection into the stomach, buttocks, thighs or upper arms. Dosing should be individualised and adjusted based on the patient’s needs.
Merilog may cause serious side effects, including hypoglycaemia, severe allergic reactions and hypokalemia (low potassium in blood). Other common side effects may include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain and swelling of hands and feet.
The FDA granted approval of Merilog to Sanofi-Aventis US.
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