Regulatory Decision Summary for Simlandi

Authorization was based on the totality of evidence presented to establish biosimilarity between Simlandi and the Canadian reference biologic drugs of Humira (adalimumab). This included pharmacology and clinical efficacy and safety studies that demonstrated comparable benefit risk profile between Simlandi and Humira.

A comparative pharmacokinetic profile between Simlandi and Humira was established in a comparative pharmacokinetic study conducted in health subjects. The confirmatory clinical study was a phase 3, multicentre, randomized, double-blind study in patients with moderate-to-severe chronic plaque psoriasis. The primary efficacy endpoint was the percent improvement in psoriasis area and severity index (PASI) from baseline to week 16. The difference in percent improvement from baseline in PASI scores to week 16 for Simlandi was compared to that for Humira and was found to be within a predefined equivalence margin to establish clinical comparability. There were no clinically meaningful differences in terms of efficacy and safety of Simlandi to the Canadian reference biologic drugs. 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 Simlandi and the Canadian reference biologic drugs.

As a biosimilar to the Canadian reference biologic drugs of Humira, Simlandi has 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 biologic drugs in line with relevant guidelines. Overall, the benefit/risk profile of Simlandi is considered to favourable for the authorized indications.