Regulatory Decision Summary for Kanjinti

Kanjinti (trastuzumab) is a humanized monoclonal antibody that selectively binds to the extracellular domain of the human epidermal growth factor receptor 2 (HER2). It was developed as a biosimilar to the Canadian reference biologic drug, Herceptin (trastuzumab).

A non-clinical data package including data from pharmacokinetic (PK), pharmacology, and toxicology studies was submitted. In vitro primary biofunctional assays were also conducted as part of the analytical comparability package.

The results from a three-way, single-dose, parallel design study in healthy male subjects comparing PK profiles of Kanjinti to Herceptin (US) and to Herceptin (EU) showed that the point estimate for the Kanjinti and Herceptin (EU) geometric least square mean ratio for Cmax was 99.0%, and the 90% confidence interval (CI) for geometric least square mean ratio for the AUCT was 94.0% - 106.0%. These results were within the equivalence margins of 80.0% to 125.0%; hence the comparable PK between Kanjinti and Herceptin (EU) was demonstrated.

In a randomized, double-blind study conducted in HER2-positive EBC patients efficacy, safety and immunogenicity between Kanjinti and Herceptin (EU) was compared. The primary efficacy endpoint was pathological complete response (pCR) after surgery following trastuzumab-containing neoadjuvant treatment. Based on the analysis in the intension-to-treat (ITT) population using non-responder imputation, the 95% CI for risk difference (RD) for pCR of central laboratory evaluation (RD: 5.1% [95% CI: (-2.0%, 12.3%]) is fully contained within the pre-specified equivalence margins of -13% to 13%. The safety profile observed was consistent with historical data on Herceptin in the adjuvant phase. Although numerical differences were seen in some adverse events between Kanjinti and Herceptin (EU) in the neoadjuvant setting, they were not considered clinically meaningful. Incidence of anti-drug antibodies (ADAs) was comparable between the treatment arms and neutralizing antibodies were not detected in patients positive for ADAs.

In accordance with Health Canadas biosimilar guidance document, a written scientific rationale was provided to support the authorization of Kanjinti in all the indications held by Herceptin, which was found satisfactory in the context of the demonstration of similarity from a quality and clinical perspective.

The final decision for this product as based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons.

A Notice of Compliance (NOC) was recommended.

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