Regulatory Decision Summary for Brenzys

The recommendation for authorization was based on scientific rationale supporting a high degree of similarity between Brenzys and the Canadian reference product. In a previous submission to Health Canada, Brenzys was evaluated through comparative quality, non-clinical and clinical studies that established biosimilarity. With the current submission, the sponsor provided a scientific rationale that discussed the mechanism of action of etanercept, pathophysiology of disease, safety profile, dosage regimen and clinical experience with the reference biologic drug to support authorization of indications in line with Health Canadas Guidance Document for biosimilar biologic products.

The final recommendation for Brenzys was based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons as discussed in the scientific rationale, which demonstrated a favourable benefit-risk profile. Aspects of safety and efficacy as well as dosing recommendations are labelled in line with the reference product in the Brenzys product monograph. The additional indications included in this submission are juvenile idiopathic arthritis, psoriatic arthritis and plaque psoriasis in adults and pediatric patients aged 4 to 17 years of age who require the full 50 mg dose.

Overall, Brenzys is considered to have a comparable and favourable benefit-risk balance to the Canadian reference product for all indications granted to the Canadian reference.