FDA Approves Merilog, a Rapid-Acting Human Insulin Analog

The FDA has approved Merilog as “biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.”

Merilog, which is a “rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes.” It is the third insulin biosimilar project to be approved by the FDA; the other two are long-acting. This approval will help to increase access to “safe, effective, and high-quality medications at potentially lower cost.”

A biosimilar is a “biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product).” 65 biosimilar products have been approved by the FDA to date.

Of the 38 million people in the U.S. diagnosed with diabetes, about 8.4 million rely on insulin therapy to manage the disease. Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, says that “having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications.”

Merilog should be administered within five to ten minutes prior to the start of the meal. It is administered subcutaneously by injection.