Sanofi's Merilog Biosimilar Wins FDA Approval for Diabetes Treatment

Sanofi’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment

The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar of Novo Nordisk’s (NYSE: NVO) NovoLog. Merilog, a rapid-acting insulin, is indicated for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. The approval includes both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 mL multiple-dose vial.

Product Details
Merilog, the first rapid-acting insulin biosimilar to receive FDA approval, should be administered within five to ten minutes prior to the start of a meal, similar to NovoLog. The drug is administered subcutaneously (under the skin) by injection into the stomach, buttocks, thighs, or upper arms, with dosage individualized based on patients’ needs.-Fineline Info & Tech

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