Regulatory Decision Summary for Rymti
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 New Drug Submission (NDS) was to seek authorization of the biosimilar Rymti for all indications authorized for the Canadian reference product Enbrel (etanercept). The sponsor was seeking all indications authorized for Enbrel based on evidence of biosimilarity and a lack of clinically meaningful difference to Rymti.
Why was the decision issued?
Authorization was based on the totality of evidence presented to establish biosimilarity between Rymti and the Canadian reference product, Enbrel (etanercept). This included demonstrating comparative non clinical, clinical, pharmacokinetics, and clinical efficacy and safety profiles.
Pharmacokinetic similarity was established between Rymti and Enbrel in a comparative bioavailability study conducted in healthy subjects. Additionally, the confirmatory clinical study was a randomized, active-controlled, double-blind, multicenter study designed to evaluate the comparative efficacy and safety of Rymti and Enbrel. The primary efficacy endpoint was the proportion of patients achieving a 20% improvement in the American College of Rheumatology (ACR20) criteria. At week 24, the proportion of patients achieving an ACR20 response was comparable between Rymti and Enbrel treatment groups. The difference in the proportion of patients achieving ACR20 was entirely contained within the predefined equivalence margin demonstrating comparability. The study supported a lack of clinically meaningful difference in terms of efficacy between Rymti and Enbrel.
The study also supported comparable safety profile, which was consistent with historical information for the reference product. The totality of evidence, including structural, functional, non-clinical, clinical pharmacokinetic and clinical efficacy and safety comparisons, provide adequate evidence to establish clinical biosimilarity between Rymti and the Canadian reference product.
Rymti demonstrated a comparable benefit/risk profile for the treatment of rheumatoid arthritis to the Canadian reference biologic drug Enbrel. Based on the sponsor’s rationale and scientific justification, this favourable profile is extended to other indications that are authorized for the Canadian reference product, in line with relevant guidelines. Overall, the benefit/risk profile of Rymti is considered to be favourable for the authorized indications.
For more information on Health Canada's decision, please view the Summary Basis of Decision.
Decision issued
Authorized; 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 |
|---|---|---|---|
| RYMTI | 02530287 | LUPIN PHARMA CANADA LIMITED | ETANERCEPT 25 MG / 0.5 ML |
| RYMTI | 02530295 | LUPIN PHARMA CANADA LIMITED | ETANERCEPT 50 MG / 1 ML |
| RYMTI | 02530309 | LUPIN PHARMA CANADA LIMITED | ETANERCEPT 50 MG / 1 ML |