Regulatory Decision Summary for Vegzelma

The submission included non-clinical data in the form of repeat-dose toxicology studies to demonstrate the biosimilarity of Vegzelma to Avastin. Based on an assessment of this study, no biologically significant differences between Vegzelma and Avastin with respect to toxicology and toxicokinetic parameters were observed. These results provide support to the comparability of Vegzelma to Avastin.

Pharmacokinetic (PK) similarity between Vegzelma and Avastin was assessed in a randomized, double-blind, single-dose, parallel group clinical trial conducted in healthy Asian male subjects. The results demonstrated that the 90% Confidence intervals (CI) for the estimated ratio of the AUC_T were within the accepted interval of 80.0% - 125.0%.

Comparability of clinical efficacy, safety and immunogenictiy was supported by the results from a randomized, double-blind study conducted in patients with newly diagnosed or recurrent stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC). Patients were randomized to receive either Vegzelma plus paclitaxel and carboplatin or Avastin plus paclitaxel and carboplatin. The trial met its primary objective of demonstrating similarity in the Objective Response Rate (ORR). The risk ratio of ORR for Vegzelma to Avastin was 1.01 and the 95% CI (0.85, 1.20) was fully contained within the pre-specified acceptance interval (0.74, 1.36). No clinically meaningful differences were observed in the comparative safety or immunogenicity between the two treatment arms.

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

In agreement with Health Canada’s biosimilar guidance document, a satisfactory scientific rationale was provided to support the authorization of Vegzelma for all of the proposed indications held by the reference product, Avastin.

A Notice of Compliance was granted.