Regulatory Decision Summary for Redesca, Redesca 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.
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What was the purpose of this submission?
This New Drug Submission was filed to seek market authorization for Redesca and Redesca HP (Enoxaparin sodium solution for injection, 100 mg/mL and 150 mg/mL) as a biosimilar to Lovenox and Lovenox HP (Enoxaparin sodium by Sanofi), the Canadian reference biologic drug, on the basis of comparative quality, non-clinical and clinical studies. All authorized indications for Lovenox are being sought.
Why was the decision issued?
Comparable pharmacodynamics (PD) between Redesca and Lovenox was established in a single dose pivotal comparative PD study using European Union (EU)-sourced reference product (known as Clexane) as an acceptable suitable proxy for the Canadian reference product in healthy subjects.
For the pivotal comparative PD study comparing Redesca with Clexane (EU), PD comparability (anti-FXa and anti-FII as the relevant PD surrogate of efficacy) was demonstrated as the 95% Confidence Intervals (CIs) for ratio of geometric means (GMR) of AUEC0-t and Amax were within the equivalence interval of 80.0% to 125.0%.
The safety profiles of Redesca were consistent with the known safety profile of Lovenox. The known risks of Lovenox have been included in the Product Monograph (PM) for Redesca. The Contraindications, Warnings and Precautions, and Adverse Reactions sections of the PM for Redesca have been retained in the PM for Redesca.
Similar efficacy and safety of Redesca as compared to Clexane (EU) were derived from the similarity of physicochemical characteristics, biological activity/potency, and the pharmacodynamic (PD) profiles. The demonstrated similarity, along with an acceptable justification based on the mechanism of action of the proposed product formed the basis of the rationale to allow extrapolation to other routes of administration and indications licensed for the reference product, Lovenox.
The final decision for Redesca was based on the totality of evidence, including comparative analytical and functional, non-clinical and pharmacodynamic (PD) comparisons in healthy volunteers. Therefore, the benefit/risk balance for Redesca is considered favourable for the indications, doses and routes of administration for which the Canadian reference product, Lovenox, are licensed and are recommended to be granted to Redesca.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| REDESCA | 02509075 | SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD. | ENOXAPARIN SODIUM 30 MG / 0.3 ML |
| REDESCA | 02509105 | SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD. | ENOXAPARIN SODIUM 80 MG / 0.8 ML |
| REDESCA | 02509113 | SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD. | ENOXAPARIN SODIUM 100 MG / ML |
| REDESCA | 02509091 | SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD. | ENOXAPARIN SODIUM 60 MG / 0.6 ML |
| REDESCA | 02509121 | SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD. | ENOXAPARIN SODIUM 300 MG / 3 ML |
| REDESCA HP | 02509156 | SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD. | ENOXAPARIN SODIUM 150 MG / ML |
| REDESCA HP | 02509148 | SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD. | ENOXAPARIN SODIUM 120 MG / 0.8 ML |
| REDESCA | 02509083 | SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD. | ENOXAPARIN SODIUM 40 MG / 0.4 ML |