Regulatory Decision Summary for Yuflyma

Authorization was based on the totality of evidence presented to establish biosimilarity between Yuflyma and the Canadian reference product, Humira (adalimumab). This included studies demonstrating comparative nonclinical, clinical pharmacokinetics, and clinical efficacy and safety profiles.

A comparative pharmacokinetic profile was established between Yuflyma and Humira in a comparative pharmacokinetic studies conducted in healthy subjects. The confirmatory clinical study was a randomized, active-controlled, double-blind, multicenter study designed to evaluate comparative efficacy and safety of Yuflyma and Humira. The primary efficacy endpoint was the proportion of patients achieving a 20% improvement in the American college of Rheumatology (ACR20) criteria. At week 24, the proportion of patients achieving ACR20 response was comparable between Yuflyma and Humira treatment groups. The difference in the proportion of patients achieving ACR20 was entirely contained within the predefined equivalence margin demonstrating clinical comparability. The study supported a lack of clinically meaningful difference in terms of efficacy between Yuflyma and Humira.

The study also supported comparable safety profile which was consistent with historical information for the reference product. The totality of evidence, including structural, functional, non-clinical, clinical pharmacokinetic and clinical efficacy and safety comparisons, provide adequate evidence to establish clinical biosimilarity between Yuflyma and the Canadian reference product.

As a biosimilar to the Canadian reference Humira, Yuflyma demonstrated comparable benefit/risk profile for the treatment of moderate-to-severe chronic plaque psoriasis. Based on the sponsor’s rationale and scientific justification, this favourable profile is extended to other indications, currently authorized for the Canadian reference product in line with relevant guidelines. Overall, the benefit/risk profile of Yuflyma is considered to the favourable for the authorized indications.