WASHINGTON — The U.S. Food and Drug Administration (FDA) just approved the first rapid-acting insulin.
It’s called Merilog. According to the FDA, the medication quickly helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes.
The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial.
Merilog is the third insulin biosimilar product approved by the FDA and joins the two long-acting insulin biosimilar products approved in 2021 by the FDA.
A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
“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,” said Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA.”
The FDA says patients can expect the same safety and effectiveness from the biosimilar as from the reference product. The FDA has approved 65 biosimilar products to treat a variety of health conditions.
According to the FDA, more than 38 million people in the U.S. have been diagnosed with diabetes. Approximately 8.4 million Americans rely on insulin therapy, either rapid-acting and/or long-acting, to manage diabetes.
Insulin is a hormone made by the pancreas, that helps glucose get into a person’s cells to be used for energy. With diabetes, the pancreas doesn’t make enough insulin to keep blood sugar levels in the normal range, which can lead to serious health problems for patients.
The FDA says Merilog should be administered within five to ten minutes before the start of a meal by injection into the stomach, buttocks, thighs, or upper arms.
Patients should always consult their doctor first before beginning a medication.
©2025 Cox Media Group
