Regulatory Decision Summary for Mvasi
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 submission was to seek authorization of Mvasi for the platinum-resistant ovarian cancer indication held by the reference biologic drug Avastin that was not claimed at the time of the original new drug submission (NDS).
Why was the decision issued?
Mvasi (bevacizumab) is a biosimilar to the Canadian authorized reference biologic drug Avastin. The similarity of Mvasi to Avastin was established in the original new drug submission (NDS) based on a thorough and comprehensive comparative quality, non-clinical and clinical studies. Given that the original similarity assessment of Mvasi remains valid, no new clinical data was submitted for this submission. Alternatively, a scientific rationale to justify the authorization of Mvasi in the proposed platinum-resistant ovarian cancer was provided.
Health Canada has thoroughly assessed the rationale provided by the sponsor taking into consideration the mechanisms of action, pathophysiological mechanisms of the disease, safety profile, immunogenicity, dosage regimen and clinical experience with the reference biologic drug, and concluded that the rationale was acceptable and in line with Health Canadas biosimilar guidance document. Therefore, the benefit-risk profile for Mvasi was considered favourable for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer.
A Notice of Compliance (NOC) was recommended for this submission.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.