FDA Greenlights Merilog: Boosting Access to Insulin 

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United States: The U.S. Food and Drug Administration granted approval to Merilog (insulin-aspart-szjj) as a biosimilar version of Novolog (insulin-aspart) to provide a new medical solution for adults and pediatric patients with diabetes mellitus. Sanofi-Aventis developed Merilog while it represents the initial biosimilar rapid-acting insulin and rapid-acting human insulin analog to obtain FDA approval in the U.S., as reported by HealthDay. 

Enhanced Blood Glucose Control Before Meals 

Merilog is designed to be administered subcutaneously shortly before meals, helping patients achieve better blood glucose control. It will be available in two forms: 

  • 3-mL prefilled pen for single-patient use 
  • 10-mL multi-dose vial 

These options provide flexibility and convenience for diabetes management.

Potential Side Effects 

While Merilog offers an effective new treatment option, patients should be aware of potential side effects, including: 

  • Severe allergic reactions 
  • Low potassium levels 
  • Injection site reactions (itching, rash, skin thickening or depression) 
  • Weight gain and swelling in hands and feet 
  • Supporting Competition and Accessibility 

The approval of Merilog by the FDA Center for Drug Evaluation and Research makes Peter Stein MD the Director of New Drugs office mark the third biosimilar insulin product granted approval by the FDA. The FDA continues its initiative to fast-track biosimilar approvals because this advance matches their current strategy to boost market competition and increase patients’ access to cost-effective insulin, as reported by HealthDay. 

The FDA maintains its dedication to maintaining access to secure medications at cheaper prices while advancing public health efforts.