Regulatory Decision Summary for Kanjinti
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 for Kanjinti for injection (420 mg trastuzumab/vial), a biosimilar to Herceptin for injection (440 mg trastuzumab/vial), was to seek market authorization for a new indication: Kanjinti 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. This indication had been authorised to Herceptin, but it was not claimed for Kanjinti in the original New Drug Submission filed by the sponsor.
Why was the decision issued?
Kanjinti is a biosimilar to the Canadian reference biologic drug Herceptin (trastuzumab 440 mg/vial). The similarity of Kanjinti to Herceptin was established in the original NDS based on data from comparative quality, comparative non-clinical, pharmacokinetics and clinical efficacy and safety studies. The similarity of Kanjinti to Herceptin remains valid; therefore, no new clinical data was provided to support the proposed indication. A scientific rationale was included to justify the authorization of the proposed indication.
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. Therefore, the risk-benefit profile of Kanjinti 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 is considered favourable.
A Notice of Compliance (NOC) was recommended.
Decision issued
Authorized; issued a Notice of Compliance with conditions in accordance with the Food and Drug Regulations