The FDA has granted approval for Merilog as a biosimilar of Novolog (insulin aspart), developed by Novo Nordisk, for the treatment of diabetes mellitus in both adults and pediatric patients to improve glycaemic control.
Merilog, from Sanofi, is the first rapid-acting insulin biosimilar to receive FDA approval. It aids in lowering blood sugar spikes after meals to enhance blood sugar management in individuals with diabetes. The approval covers a 3-ml single-use prefilled pen and a 10-ml multiple-dose vial.
This marks the third insulin biosimilar approval by the FDA, following the approval of two long-acting insulin biosimilars in 2021. Biosimilars are biological products that closely resemble and have no clinically significant differences from an FDA-approved reference product, providing patients with the same safety and efficacy.
To date, the FDA has approved 65 biosimilar products for various health conditions. Insulin, a hormone produced by the pancreas, facilitates the entry of glucose into cells for energy utilization. In diabetes, insufficient insulin production by the pancreas can lead to elevated blood sugar levels and serious health complications.
Similar to Novolog, Merilog is administered five to ten minutes before meals via subcutaneous injection in the abdomen, buttocks, thighs, or upper arms. Dosage adjustments are made based on individual patient requirements.
While Merilog can effectively improve blood sugar management, it may also pose risks of hypoglycemia, severe allergic reactions, and hypokalemia. Common side effects include injection site reactions, itching, rash, lipodystrophy, weight gain, and edema in the extremities.
(Source: USFDA)
Published on February 23, 2025
