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 Supplemental New Drug Submission (SNDS) was to support the use of Mvasi (bevacizumab), a biosimilar to the reference biologic drug Avastin (bevacizumab), in combination with lomustine, for the treatment of patients with glioblastoma after relapse or disease progression, following prior therapy.
Why was the decision issued?
The decision to authorize Mvasi (bevacizumab), in combination with lomustine, in the treatment of patients with glioblastoma after relapse or disease progression, following prior therapy, is based on a scientific rationale. In line with Health Canadas biosimilar guidance document, the scientific rationale provided by the sponsor was reviewed and it was considered justifiable to grant the indication based on the established similarity profile.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations