Regulatory Decision Summary for Myxredlin
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this biosimilar New Drug Submission is to seek market authorization of Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection) for the treatment of diabetes mellitus in patients who require insulin by intravenous administration for the control of hyperglycemia. To support the application, safety and efficacy of the product was compared to that of Novolin ge Toronto administered intravenously.
After evaluation of the submitted data package, Health Canada authorized Myxredlin for the following indications:
“Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection) is indicated for:
- The treatment of patients with diabetes mellitus who require insulin by intravenous administration for the control of hyperglycemia.
Myxredlin, using intravenous administration, should be used for the treatment of emergencies, such as diabetic coma and pre-coma, and in diabetics undergoing surgery. (See also Contraindications)”
Why was the decision issued?
- Diabetes mellitus is a metabolic disorder characterized by the presence of hyperglycemia due to defective insulin secretion and/or the development of insulin resistance.
- Authorization was based on a single euglycemic clamp trial in 60 healthy subjects with the primary objective of assessing the biosimilarity of Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection) with Actrapid-EU (a suitable proxy for the Canadian Reference Product, Novolin ge Toronto). Pre-defined comparability margins of 80.0% to 125.0% for 90% confidence intervals (CIs) for the primary Pharmacokinetic (PK) endpoints were met. Pre-defined comparability margins of 80.0% to 125.0% for 95% CIs for the primary Pharmacodynamic (PD) endpoints were also met. Therefore, this study confirmed PK and PD similarity between Myxredlin and Actrapid-EU.
- The safety profile of Myxredlin was consistent with the reference biologic drug, Novolin ge Toronto. No clinically meaningful imbalances were noted in the type, frequency, seriousness, or severity of TEAEs or SAEs were noted.
- The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons.
- Overall, based on the data and information provided to support this application, the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) concluded that there is a positive benefit-risk profile for Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection) to be used for the treatment of patients with diabetes mellitus who require insulin by IV administration for the control of hyperglycemia.
For more information on Health Canada's decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| MYXREDLIN | 02529602 | BAXTER CORPORATION | INSULIN (HUMAN) 1 UNIT / ML |