For the purpose of improving glycemic control in adults and pediatric patients with diabetes mellitus, the U.S. Food and Drug Administration authorized Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart). The first rapid-acting insulin biosimilar product to receive FDA approval is Merilog, a human insulin analog. Merilog, a rapid-acting insulin, helps diabetics better control their blood sugar by reducing blood sugar rises during meals. Both a 10 milliliter (mL) multiple-dose vial and a 3 milliliter (mL) single-patient-use prefilled pen have received approval. 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. Approval of biosimilar products can increase patient access to safe and effective treatment options.
Medication for a variety of severe diseases and long-term health issues, such as diabetes, is a biological product. A biosimilar is a biological product that is very similar to an FDA-approved biological product (also known as the reference product) and differs from it in no clinically significant ways. Patients can anticipate that the biosimilar will be just as safe and effective as the reference product. For a range of medical ailments, the FDA has so far authorized 65 biosimilar medicines.
More than 38 million people in the U.S. have been diagnosed with diabetes, a disease that occurs when blood glucose (sugar) is too high. Approximately 8.4 million Americans rely on insulin therapy, either rapid-acting and/or long-acting, to manage diabetes. Insulin, a hormone made by the pancreas, 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.
Merilog should also be taken five to ten minutes before meals, much like Novolog. Merilog is injected subcutaneously, or beneath the skin, into the upper arms, thighs, buttocks, or stomach. Merilog dosage should be adjusted and modified according to each patient's need.
Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions and hypokalemia (low potassium in blood). Other common side effects may include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain and swelling of hands and feet.
Learn more: FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes | FDA
