The U.S. Food and Drug Administration (FDA) has approved insulin aspart-szjj (Merilog), the first rapid-acting insulin biosimilar. Like insulin aspart (NovoLog) — the product it’s based on — Merilog helps manage blood sugar spikes around mealtime for people living with diabetes. This approval marks the third insulin biosimilar available in the U.S., offering another option that may lead to more affordable diabetes care.

“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, as biosimilar products have the potential to increase access to these lifesaving medications,” said Dr. Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

Merilog is the first fast-acting insulin biosimilar. The two other insulin biosimilars are long-acting: insulin glargine-yfgn (Semglee) and insulin glargine-aglr (Rezvoglar), both alternatives to insulin glargine (Lantus). Biosimilars are designed to work the same way as their brand-name counterparts, with no meaningful differences in safety or effectiveness.

Merilog comes in two forms: a prefilled injection pen and a multidose vial. It’s taken shortly before meals to help keep blood sugar levels in a healthy range. Like other insulins, it must be tailored to individual needs.

As with all insulin products, Merilog may cause side effects such as low blood sugar and allergic reactions.

A Growing Pool of Biosimilar Insulin Products

For the more than 8 million Americans who rely on insulin daily, biosimilar products could improve access and affordability. Biosimilars often cost less than brand-name drugs, helping reduce out-of-pocket expenses.

Still, individual responses can vary. Some people may need time to adjust to a new medication or might experience different side effects. Always work with your healthcare provider to find the insulin that’s right for your needs.

Learn more about the different types of insulin and other treatments for managing type 2 diabetes.

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