Regulatory Decision Summary for Hyrimoz

Authorization was based on the totality of evidence presented to establish biosimilarity between Hyrimoz and Humira (adalimumab). This included studies demonstrating comparative nonclinical and clinical efficacy and safety. The confirmatory clinical study was a phase 3, multicenter, randomized, double-blind trial in patients with chronic, moderate-to-severe chronic plaque psoriasis. This study included 465 patients with plaque psoriasis receiving either Humira or Hyrimoz for up to 51 weeks. The primary endpoint was the PASI 75 response at week 16. The difference in the PASI 75 response rate at week 16 was compared to Humira and was found to be within a predefined comparability margin to establish clinical comparability. There were no clinically meaningful differences in terms of efficacy and safety of Hyrimoz to the Canadian reference product. The totality of evidence, including structural, functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons, provide adequate evidence to establish clinical biosimilarity between Hyrimoz and the Canadian reference.

As a biosimilar to the Canadian reference product Humira, Hyrimoz has demonstrated a comparable benefit/risk profile for the treatment of plaque psoriasis. This favourable profile is extended to other indications currently authorized for the Canadian reference product and sought by the sponsor based on scientific rationale in line with relevant guidelines such as "Information and Submission requirements for Biosimilar Biologic Drugs". Pediatric indications (Crohns Disease and polyarticular juvenile idiopathic arthritis patients requiring less than 40 mg) were not authorized due to the current absence of a formulation capable of delivering less than the full 40 mg dose. Overall, the benefit/risk profile of Hyrimoz is considered to be similar and favourable for the authorized indications.

For more information on Health Canadas decision, please view the Summary Basis of Decision.