February 16, 2025 | BioPatrika News Desk
In a significant advancement for diabetes care, the U.S. Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart), marking the first-ever approval of a rapid-acting insulin biosimilar. The approval is expected to enhance accessibility and affordability of insulin for millions of diabetes patients in the United States.
A New Era in Diabetes Treatment
Merilog, a rapid-acting human insulin analog, is designed to reduce mealtime blood sugar spikes and improve glycemic control in adults and children with diabetes mellitus. The FDA’s approval includes two formulations:
- 3 mL single-patient-use prefilled pen
- 10 mL multiple-dose vial
This approval adds Merilog to the list of FDA-approved biosimilar insulin products, following the two long-acting insulin biosimilars granted approval in 2021.
Driving Competition and Reducing Costs
“The FDA has now approved three biosimilar insulin products to treat diabetes,” stated Dr. Peter Stein, Director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. He emphasized the agency’s commitment to streamlining the biosimilar approval process, fostering competition, and improving patient access to essential medications at a potentially lower cost.
Why Biosimilars Matter
Biosimilars are highly similar to already approved biological products (reference drugs) and exhibit no clinically meaningful differences in safety, effectiveness, and quality. Their availability expands treatment options and helps address the rising costs of insulin therapy. To date, the FDA has approved 65 biosimilar products for various chronic and life-threatening conditions.
Diabetes and the Need for Accessible Insulin
Diabetes affects over 38 million people in the U.S., with 8.4 million individuals relying on insulin therapy to manage their condition. Insulin regulates blood sugar levels, and an inadequate supply can result in serious complications.
Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars at the FDA, highlighted the significance of biosimilar insulin: “For millions of patients who depend on daily insulin injections, the introduction of a rapid-acting biosimilar like Merilog can be a game-changer, making these life-saving treatments more accessible.”
Administration and Safety Considerations
Merilog should be administered 5-10 minutes before meals, via subcutaneous injection in the stomach, thighs, buttocks, or upper arms. The dosage should be adjusted based on individual patient needs.
Potential side effects include:
- Serious risks: Hypoglycemia (low blood sugar), severe allergic reactions, hypokalemia (low potassium levels).
- Common side effects: Injection site reactions, itching, rash, lipodystrophy (skin thickening), weight gain, and swelling in hands and feet.
Approval and Manufacturer
The FDA has granted approval of Merilog to Sanofi-Aventis U.S. LLC. The company is expected to roll out the biosimilar in the coming months, providing diabetes patients with an alternative and potentially cost-effective insulin option.
For more details, visit the FDA press release.
