Regulatory Decision Summary for Ogivri

The similarity of Ogivri to Herceptin has been established based on comparative analytical and functional, non-clinical and clinical studies. From a clinical perspective, the results of two pharmacokinetic (PK) studies in healthy volunteers showed PK similarity between Ogivri and Herceptin. The 90% confidence intervals (CIs) of the tested PK parameters were all within the acceptance margins of 80.0% to 125.0%. The determination of no clinically meaningful differences between Ogivri and Herceptin in terms of efficacy and safety was further evidenced by the results of the comparative clinical study conducted in HER2-positive untreated metastatic breast cancer (MBC) patients. The primary efficacy analysis demonstrated that the 95% CI of the risk ratio of objective response rate (ORR) was contained within the pre-defined interval of 0.81 to 1.24. The secondary and sensitivity analyses were supportive of the primary efficacy results. Although numerical differences in some adverse events were reported between the two arms, they were not considered to be clinically meaningful. Furthermore, the incidence of anti-drug antibodies (ADAs) was low and comparable in both treatment arms.

Based on the totality of evidence derived from the comparative structural and functional, non-clinical and clinical data, similarity between Ogivri and Herceptin has been demonstrated. To further support the authorization of Ogivri in each of the proposed indications, the sponsor provided a scientific rationale that was in line with Health Canadas biosimilar guidance document. Based on the assessment of all the relevant data provided in the submission, Ogivri is considered to have a risk-benefit profile that is favourable for the treatment of HER2-postive early breast cancer (EBC), MBC and metastatic gastric cancer (MGC) patients.

For more information on Health Canadas decision, please view the Summary Basis of Decision.