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Sanofi Announces MERILOGTM (insulin aspart-szjj) injection 100 Units/mL the first FDA approved biosimilar to NovoLog® in the US.1

  • MERILOG is a mealtime insulin, approved for the management of Diabetes. 

MERILOG is available in the following dosage forms2:

  • MERILOG (insulin aspart szjj) 3mL x 5 injection Pen 
  • MERILOG (insulin aspart szjj) 10mL Vial

There are no clinically meaningful differences between MERILOG (insulin aspart szjj) injection 100 Units/mL and Novolog.

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How does a Biosimilar work?

MERILOG is a highly similar biologic to NovoLog® (insulin aspart injection) in pharmacology, efficacy, safety, and dosing.2,3

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Learn more about cost and savings coverage for MERILOG

Savings
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MERILOG 1:1 unit dosing with NovoLog and is available in the SoloStar®

1:1 Dosing
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A similar PK/PD profile (identical amino acid sequence) to that of NovoLog3

Clinical Studies
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MERILOG has an identical amino acid sequence to that of NovoLog3

MERILOG is produced by recombinant DNA technology and has the same structure as NovoLog3

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MERILOG was found to be similar to NovoLog 100 U/mL4

A phase 1 study in patients with T1D assessed PK/ PD similarity to NovoLog3,5 
The phase 3 GEMELLI 1 study in patients with T1D or T2D assessed efficacy and safety compared to those of NovoLog4

See the data here

Phase 1 PK/PD Study Design: A single-center, randomized, double-blind, 3-period, 6-sequence, euglycemic clamp crossover study conducted in 30 adult male subjects with T1D. Subjects received 0.3 U/kg of each treatment (MERILOG, NovoLog, or a non–US-approved insulin aspart) under fasted conditions and underwent a 12-h euglycemic clamp technique to assess PK/PD activity for up to 12 h. The primary PK/PD endpoints were the areas under the plasma insulin concentration–time curve from time zero to INS-AUClast and extrapolated to INS-AUCinf, INS-Cmax, and the areas under the body weight-standardized GIR-AUC0-12h among the 3 treatments.3

Phase 3 GEMELLI 1 Study Design: An open-label, multicenter, parallel-group, phase 3 clinical trial conducted in 597 adult subjects with T1D or T2D. Subjects were randomized 1:1 to receive 100 U/mL (dose range 1-80 U) of the treatment drug (MERILOG or NovoLog) SC before meals with Gla-100 QD up to Week 52. The primary endpoint was the change in A1C from baseline to Week 26. The secondary endpoints were the percentage of study participants with A1C <7.0% 
 (<53 mmol/mol), changes in FPG from baseline to Week 26 and Week 52, changes in the mean 24-h plasma glucose concentration from baseline to 
 Week 26 and Week 52, and PPG excursions from baseline to Week 26 and Week 52. The 6-month extension aimed to evaluate the efficacy, safety, and immunogenicity of MERILOG during the entire 12-month period.4,6,7

A1C, Hemoglobin A1c; INS-AUClast, Insulin Area Under the Curve to last measurable concentration;  INS-AUCinf, Insulin Area Under the Curve extrapolated to infinity; INS-Cmax, Maximum Plasma Concentration of Insulin; DNA, Deoxyribonucleic Acid; FDA, Food and Drug Administration; FPG, Fasting Plasma Glucose;  GIR-AUC0–12h, Glucose Infusion Rate Area Under the Curve from 0 to 12 hours; PD, Pharmacodynamics;  PK, Pharmacokinetics; PPG, Postprandial Glucose; T1D, Type 1 Diabetes; T2D, Type 2 Diabetes; QD, Once Daily; US, United States.

Important Safety Information

Contraindications 
MERILOG is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin aspart products or any of the excipients in MERILOG.

Warnings and Precautions
Never share a MERILOG SoloStar® prefilled pen between patients, even if the needle is changed: Sharing poses a risk for transmission of blood-borne pathogens. 

Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. Changes in insulin regimen may affect glycemic control and predispose to hyperglycemia or hypoglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia. 

Hypoglycemia is the most common adverse reaction associated with insulins, including MERILOG and may be life-threatening. 

Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between MERILOG and other insulins, instruct patients to always check the insulin label before each injection. 

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including MERILOG. If hypersensitivity reactions occur, discontinue MERILOG, treat per standard of care and monitor until symptoms and signs resolve. 

All insulin products, including MERILOG, can cause hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia. 

Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, and particularly when used with insulin. Observe for signs and symptoms of heart failure. Consider dosage reduction or discontinuation of TZD if heart failure occurs. 

Adverse Reactions
Adverse reactions observed with insulin aspart products include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. 

Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine). 

Important Safety Information for MERILOG SoloStar
MERILOG SoloStar is a disposable single-patient-use prefilled insulin pen. To help ensure an accurate dose each time, patients should follow the steps in the Instruction Leaflet accompanying the pen; otherwise, they may not get the correct amount of insulin, which may affect their blood glucose levels.

Click here for full Prescribing information for MERILOG.
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Indication

MERILOG is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Important Safety Information

Indication

References 

1. U.S. Food and Drug Administration. FDA Approves First Rapid-Acting Insulin Biosimilar Product for the Treatment of Diabetes. Available at:  https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes. Accessed June 17, 2025.

2. MERILOG Prescribing Information. Sanofi.

3. Kapitza C, Nosek L, Schmider W, Teichert L, Nowotny I. Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes. Diabetes Technol Ther. 2020;22(4):278-284.

4. Garg SK, Wernicke-Panten K, Wardecki M, et al. Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1). Diabetes Technol Ther. 2020;22(2):85-95.

5. ClinicalTrials.gov. NCT03202875. Available at: https://clinicaltrials.gov/study/NCT03202875. Accessed June 17, 2025.

6. Garg SK, Wernicke-Panten K, Wardecki M, et al. Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial. Diabetes Technol Ther. 2020;22(7):516-526.

7. ClinicalTrials.gov. NCT03211858. Available at: https://clinicaltrials.gov/study/NCT03211858. Accessed June 17, 2025.

NovoLog is a registered trademark of Novo Nordisk A/S MAT-US-2502958-v1.0-07/2025

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