Sanofi-Aventis US has received the US Food and Drug Administration (FDA) approval for Merilog (insulin-aspart-szjj), a biosimilar to Novo Nordisk’s Novolog (insulin aspart).
Merilog is a rapid-acting human insulin analogue, indicated for the improvement of glycaemic control in adults and paediatric patients with diabetes mellitus.
The drug works to reduce mealtime blood sugar spikes to improve control of blood sugar in people with diabetes.
According to the FDA, Merilog is the first rapid-acting insulin biosimilar product, and the third insulin biosimilar product approved in the US.
The drug is offered as 3mL single-patient-use prefilled pens and 10mL multiple-dose vials.
FDA Centre for Drug Evaluation and Research office of new drugs director Peter Stein said: “The FDA has now approved three biosimilar insulin products to treat diabetes.
“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.
“Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA.”
A biosimilar is a biological product that is mostly similar to an already FDA-approved reference product, with no clinically meaningful differences.
Similar to Novolog, Merilog will be administered within five to ten minutes before the meal, as a subcutaneous injection into the stomach, buttocks, thighs or upper arms.
Its dosing will be personalised and adjusted according to the patient’s needs.
FDA said the drug may cause serious side effects, including hypoglycaemia (low blood sugar), severe allergic reactions and hypokalaemia (low potassium in blood).
It may also cause other side effects, including injection site reactions, itching, rash, lipodystrophy (skin thickening), weight gain and swelling of hands and feet.
FDA Centre for Drug Evaluation and Research office of therapeutic biologics and biosimilars director Sarah Yim said: “For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference.”
