Regulatory Decision Summary for Herzuma
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 market authorization for Herzuma (transtuzumab) in combination with pertuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Why was the decision issued?
Herzuma is a biosimilar to the innovator product Herceptin. The similarity between Herzuma and Herceptin was demonstrated by comparative quality, non-clinical and clinical studies in the original new drug submission. No new clinical data were submitted as the original similarity assessment remains valid. Alternatively, a summary of previous comparative studies and a scientific rationale to justify the authorization of new indication for Herzuma was provided.
Health Canada has thoroughly evaluated the results of previous studies and rationale, which demonstrates similarity between Herzuma and Herceptin in structure, functional attributes, pharmacokinetics, efficacy, safety, and immunogenicity. It is concluded that the information and rationale provided by the sponsor was acceptable and in line with Health Canadas biosimilar guidance document. Therefore, the benefit-risk profile of Herzuma was considered favourable for the new indication.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.