Regulatory Decision Summary for Erelzi
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 supplemental new drug submission (SNDS) was to seek authorization for a proposed additional indication (psoriatic arthritis; PsA), as per the reference biologic drug, that was not claimed at the time of the original NDS, and for a proposed age-related modification to a currently held indication, juvenile idiopathic arthritis (JIA).
Why was the decision issued?
No new clinical or non-clinical data was submitted to support this SNDS. The Sponsor submitted a detailed rationale that scientifically justifies authorization of the biosimilar in the proposed psoriatic arthritis indication taking into consideration the mechanisms of action, pathophysiological mechanisms of the disease, safety profile, dosage regimen, and clinical experience with the reference biologic drug.
The rationale for the proposed addition of the PsA indication and modifications to the authorized Product Monograph (PM) as included in the submission, were examined within the Clinical review.
The proposed addition of the PsA indication was considered to be in accordance with Health Canadas biosimilar guidance document. The age-related information associated with the JIA indication was harmonized to reflect that included in the PM for the reference biologic drug.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.