Regulatory Decision Summary for Riximyo
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this submission was to seek authorization to add an indication for Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) to the rituximab biosimilar, Riximyo.
Why was the decision issued?
Granulomatosis with polyangiitis (GPA) and Microscopic Polyangiitis (MPA) are progressive small vessel vasculitis with overlapping clinical features of necrotizing vasculitis affecting the lungs, kidneys and skin. Clinical studies have demonstrated an efficacious response in patients with GPA and MPA treated with Rituxan (rituximab).
In 2020, Health Canada authorized Riximyo as a biosimilar to Canadian reference drug Rituxan.
The demonstration of biosimilarity was based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons that demonstrated a lack of meaningful difference between the two. In addition, in this submission, the sponsor provided a supportive scientific justification as set out in Health Canadas Guidance Document: Information and Submission Requirements for Biosimilars Biologic Drugs. This detailed rationale described the same mechanism of action, safety profile, dosage regimen and clinical experience with Riximyo compared to the reference drug and described the pathophysiological mechanisms of GPA and MPA.
The Product Monograph for Riximyo includes the efficacy, safety and dosing information important for the use of Riximyo in patients with GPA/MPA.
Overall, Riximyo has a comparable and favourable benefit/risk balance as the Canadian reference product for the induction of remission in adult patients with severely active GPA and MPA.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations