Regulatory Decision Summary for Adalimumab Injection

Authorization was based on the totality of evidence presented to establish biosimilarity between PF-06410293 and the Canadian reference product, Humira (adalimumab). This included studies demonstrating comparative nonclinical, clinical pharmacology, and clinical efficacy and safety profiles.

A comparable pharmacokinetic profile between PF-06410293 and EU-sourced HUMIRA was established in a comparative pharmacokinetic study conducted in healthy subjects. The confirmatory clinical study was a phase 3, multicenter, randomized, double-blind trial in patients with moderately to severely active rheumatoid arthritis. The primary endpoint was the 20% improvement in the American College of Rheumatology clinical response criteria (ACR20) at week 12. The difference in the ACR20 response rate at week 12 for PF-06410293 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 PF-06410293 to the Canadian 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 PF-06410293 and the Canadian reference product.

As a biosimilar to the Canadian reference product Humira, PF-06410293 has demonstrated a comparable benefit/risk profile for the treatment of rheumatoid arthritis. Additionally, based on the scientific justification and the sponsors rationale, 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 PF-06410293 is considered favourable for the authorized indications.