Regulatory Decision Summary for Ogivri

Ogivri was developed as a biosimilar to the Canadian reference biologic drug, Herceptin. The biosimilarity of Ogivri to Herceptin was established in the original New Drug Submission based on data from comparative quality, non-clinical, pharmacokinetics and clinical efficacy and safety studies. The similarity of Ogivri to Herceptin remains valid; therefore, no new clinical data were provided to support the proposed indication. A detailed scientific rationale was used to justify the authorization of the proposed indication.

Health Canada has thoroughly assessed the scientific rationale provided by the Sponsor taking into consideration the analytical similarity, mechanisms of action, pathophysiological mechanisms of the disease, pharmacokinetics, safety profile, immunogenicity, dosage regimen and clinical experience with the reference biologic drug. Based on the totality of the evidence provided, it was concluded that the rationale was acceptable. Therefore, the benefit/risk profile for Ogivri 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.