Merilog FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 18, 2025.
FDA Approved: Yes (First approved February 14, 2025)
Brand name: Merilog
Generic name: insulin aspart-szjj
Dosage form: Injection
Company: Sanofi
Treatment for: Diabetes Mellitus
Merilog (insulin aspart-szjj) is a rapid acting human insulin analog biosimilar to NovoLog (insulin aspart) indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
- Merilog is biosimilar to NovoLog and does not have an interchangeability designation.
- Merilog is supplied as 100 units/mL (U-100) of insulin aspart-szjj injection in a 10 mL multiple-dose vial and 3 mL single-patient-use Merilog SoloStar prefilled pen.
- Merilog is administered by subcutaneous injection.
- FDA approval of Merilog was based on data that demonstrated that Merilog is biosimilar to NovoLog.
- Warnings and precautions associated with Merilog include hyperglycemia or hypoglycemia with changes in insulin regimen, hypoglycemia which may be life-threatening, hypersensitivity reactions, and hypokalemia.
- Adverse reactions observed with insulin aspart products include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.
- Merilog is the first FDA-approved biosimilar to NovoLog.
Development timeline for Merilog
| Date | Article |
|---|---|
| Feb 16, 2025 | Approval FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog |
Further information
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