Regulatory Decision Summary for Axberi / Axberi HP
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.
Type of Submission:
New Drug Submission
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
Baxter Corporation filed a New Drug Submission (NDS) for Axberi (enoxaparin sodium solution, 100 mg/mL) and Axberi HP (enoxaparin sodium solution, 150 mg/mL), in pre-filled syringe (PFS) for intravenous (IV) and subcutaneous (SC) administration, as biosimilars to the Canadian Reference Biologic Drugs, Lovenox (enoxaparin sodium solution, 100 mg/mL) and Lovenox HP (enoxaparin sodium solution, 150 mg/mL) in PFS for IV and SC administration. Axberi and Axberi HP are intended for the same indications that are currently authorized for Lovenox and Lovenox HP in Canada, i.e. indicated for the prophylaxis of thromboembolic disorders, deep vein thrombosis; the prevention of thrombus formation in the extra-corporeal circulation during hemodialysis; the treatment of deep vein thrombosis, unstable angina or non-Q-wave myocardial infarction, and acute ST-segment elevation myocardial infarction
The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.
Why was the decision issued?
To support the biosimilarity of Axberi and Axberi HP to Lovenox and Lovenox HP, comparative structural, functional, non-clinical, pharmacodynamic (PD) results were provided.
The results of the non-clinical studies demonstrated that Axberi Drug Product lots were comparable to Lovenox Drug Product lots using various laboratory methods.
The results from a randomized, single-dose, cross-over study in healthy adult subjects demonstrated comparable PD profiles of anti-Xa and anti-IIa between Axberi and Lovenox. The PD parameters were within the pre-defined margins. In a supportive comparative PD study, comparative PD profiles of anti-Xa and anti-IIa between Axberi and Lovenox were also demonstrated. In addition, the supportive data indicated comparable PD profiles of baseline-corrected tissue factor pathway inhibitor (TFPI), baseline-uncorrected TFPI and ratio of anti-Xa/anti-IIa between the biosimilar and reference products.
With respect to safety, data from these studies demonstrated that the test and reference products were well tolerated. No clinically meaningful differences between the biosimilar and reference products were observed in the studies.
In accordance with Health Canada's biosimilar guidance document, a written scientific rationale was provided to support the authorization of Axberi and Axberi HP for all the indications held by Lovenox and Lovenox HP, which was found satisfactory in the context of demonstration of biosimilarity.
The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical and clinical comparative pharmacodynamic comparisons. Overall, as the evidence demonstrated similarity of Axberi / Axberi HP to Lovenox/Lovenox HP, the benefit/risk profile of Axberi / Axberi HP is considered favourable for the prophylaxis of thromboembolic disorders or deep vein thrombosis; the prevention of thrombus formation in the extra-corporeal circulation during hemodialysis; the treatment of deep vein thrombosis, unstable angina or non-Q-wave myocardial infarction, and acute ST-segment elevation myocardial infarction.
A Notice of Compliance (NOC) was recommended.
For further details about Axberi / Axberi HP, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
Schedule D drug
Related Drug Products
|Active ingredient(s) & strength
|ENOXAPARIN SODIUM 40 MG / 0.4 ML
|ENOXAPARIN SODIUM 150 MG / ML
|ENOXAPARIN SODIUM 100 MG / ML
|ENOXAPARIN SODIUM 30 MG / 0.3 ML
|ENOXAPARIN SODIUM 60 MG / 0.6 ML
|ENOXAPARIN SODIUM 120 MG / 0.8 ML
|ENOXAPARIN SODIUM 80 MG / 0.8 ML