Today, the U.S. Food and Drug Administration (FDA) approved  Merilog (insulin aspart szij) as a biosimilar product to Novolog (insulin aspart) to improve glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, 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 reduce blood sugar spikes during meals to improve blood sugar control in people with diabetes. The approval is for both a single-use 3 milliliter (mL) prefilled patient pen and a 10 milliliter (mL) multi-dose vial.

Merilog is the third FDA-approved insulin biosimilar product and joins the two long-acting insulin biosimilar products approved by the FDA in 2021. Approval of biosimilar products may increase patient access to safe and effective treatment options.    

“The FDA has now approved three insulin biosimilar products to treat diabetes,” said Peter Stein , M.D., director of the Office of New Drugs (OND) in the FDA’s Center for Drug Evaluation and Research (CDER). “Today’s approval highlights our ongoing efforts to improve the efficiency of the biosimilar approval process to contribute to a competitive marketplace and increase options for expensive treatments, such as insulin. Increasing access to safe, effective, high-quality medicines at potentially lower cost remains an ongoing priority for the FDA.”

Biologics include medicines used to treat many serious diseases and chronic conditions, including diabetes. A biosimilar is a biologic product that is very similar to an FDA-approved biologic product (also called a reference product) but has no clinically meaningful differences from the reference product. This means that patients can expect the same safety and effectiveness of the biosimilar as the reference product. To date, the FDA has approved 65 biosimilar products for a variety of conditions.

More than 38 million people in the United States have been diagnosed with diabetes, a disease that occurs when blood glucose (sugar) levels are too high. About 8.4 million people in the United States rely on insulin treatment, either fast-acting or long-acting, to control diabetes. Insulin, a hormone produced by the pancreas, helps glucose enter cells and be used for energy. Due to diabetes, the pancreas does not produce enough insulin to keep blood sugar levels within normal limits, which can cause serious health problems for patients.

"For the millions of people who rely on daily insulin injections for the treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can really make a difference, as biosimilar products have the potential to increase access to these life-saving medicines," said Sarah Yim , M.D., director of the Office of Therapeutic Biologics and Biosimilars (OTBB) in the FDA's Center for Drug Evaluation and Research.

Merilog can cause serious side effects, such as hypoglycemia (low blood sugar), severe allergic reactions, and hypokalemia (low potassium in the blood). Other common side effects may include injection site reactions, itching, skin rash, lipodystrophy (thickening of the skin or pitting at the injection site), weight gain, and swelling of the hands and feet.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Source: prnewswire.com

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