Regulatory Decision Summary for Elonox / Elonox HP

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.


Product type:

Drug

Medicinal ingredient(s):

Enoxaparin Sodium

Therapeutic area:

Anticoagulant/Antithrombotic Agent

Type of submission:

New Drug Submission

Control number:

243026
What was the purpose of this submission?

 

Fresenius Kabi Canada Ltd., filed a New Drug Submission (NDS) for Elonox (enoxaparin sodium solution, 100 mg/mL) and Elonox 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. Elonox and Elonox HP are intended for the same indications that are currently authorized to Lovenox and Lovenox HP in Canada, i.e. 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.

 

Why was the decision issued?

 

To support the biosimilarity of Elonox and Elonox HP to Lovenox and Lovenox HP, comparative structural, functional, non-clinical, pharmacodynamic (PD) results were provided. 

The results of the non-clinical studies, including a comparative toxicological study, were considered satisfactory in demonstrating the comparability of Elonox to a proxy of the Canadian Reference Biologic Drug of Lovenox: Clexane (enoxaparin sodium solution, 100 mg/mL), manufactured by Sanofi-Aventis Deutschland GmbH, Germany.

The results from a two-way, single-dose, cross-over study in healthy adult male subjects comparing PD profiles of anti-Xa between Elonox and Clexane showed that the point estimate for the Elonox and Clexane geometric least square mean ratio for maximum anti-Xa activity (anti-Xamax) was 106.5%, and the 95% confidence interval (CI) for geometric least square mean ratio for AUEC0-t (area under effect in plasma versus time curve from time zero to the last measurable effect) of anti-Xa was 107.9 – 115.3%. These results were within the equivalence margins of 80.0% to 125.0%; hence the comparable PD between Elonox and Clexane has been demonstrated for anti-Xa.

The comparative criteria with respect to anti-IIa, i.e. anti-IIamax and AUEC0-t, were also met. The results of ratio of anti-Xa to anti-IIa, baseline-uncorrected and baseline-corrected tissue factor pathway inhibitor between the biosimilar and reference product are supportive of comparative PD.

Data from this study demonstrated that the test and reference products were well tolerated. No clinically meaningful differences between the biosimilar and reference product were observed in the study.

In accordance with Health Canada's biosimilar guidance document, a written scientific rationale was provided to support the authorization of Elonox and Elonox HP for all the indications held by Lovenox and Lovenox HP, which was found satisfactory in the context of the demonstration of biosimilarity from a quality and clinical perspective.

The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical and clinical comparative pharmacodynamic comparisons.

A Notice of Compliance (NOC) was recommended.

 

Decision issued

Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.

Date of decision:

2022-10-26

Manufacturer:

Fresenius Kabi Canada Ltd.

Drug Identification Numbers issued:

  • DIN 02532255 (40 mg / 0.4 mL)
  • DIN 02532247 (30 mg / 0.3 mL)
  • DIN 02532263 (60 mg / 0.6 mL)
  • DIN 02532271 (80 mg / 0.8 mL)
  • DIN 02532298 (100 mg / mL)
  • DIN 02532301 (120 mg / 0.8 mL)
  • DIN 02532328 (150 mg / mL)

Prescription status:

Available by prescription only

Date filed:

2021-10-27

Contact:

Office of Regulatory Affairs - Biologic and Radiopharmaceutical Drugs Directorate (ORA-BRDD)
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