Regulatory Decision Summary for Riximyo
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.
ATC code: L01XC02
Type of submission:
What was the purpose of this submission?
This New Drug submission (NDS) was submitted to authorize the use of Riximyo (rituximab), a biosimilar biologic drug, for some of the indications and uses currently held by Rituxan (the reference product) in Canada: non-Hodgkin lymphoma (various indications), chronic lymphocytic leukemia and rheumatoid arthritis.
Why was the decision issued?
Riximyo was developed as a biosimilar to the Canadian reference biologic drug, Rituxan (rituximab). The market application relied on comparisons made to demonstrate similarity to the Canadian authorized product, Rituxan.
For the nonclinical and clinical review streams, the sponsor submitted a nonclinical data package which included pharmacokinetic (PK), pharmacology, and toxicology program elements. In vitro primary bio-functional assays were also conducted as part of the analytical comparability package.
The clinical development program consisted of two pivotal studies:
- a pharmacokinetic (PK) study in rheumatoid arthritis patients who had inadequate disease control on at least one and up to three prior anti-TNF treatments. The 90% confidence intervals (CIs) of the PK parameters (AUCT, and Cmax [as point estimate]) were within the acceptance margins of 80.0% to 125.0%. The PK study was supported by additional PK-related data in the patient population. The PK study also provided supportive evidence of no clinically meaningful differences in safety and efficacy, between Riximyo and the reference product.
- a comparative clinical efficacy and safety study conducted among patients with untreated advanced follicular lymphoma. The primary efficacy analysis demonstrated that the 95% CI of the objective response rates (ORR) was contained within the pre-defined interval of -12% to 12%. The safety profiles of the biosimilar and reference products were considered comparable.
The sponsor proposes identical dosage and dosing regimens for the use of Riximyo in the claimed indications as those currently in use by the reference product.
A scientific rationale, provided to support the authorization of Riximyo in the proposed indications held by the reference product Rituxan, was considered in accordance with Health Canadas biosimilar guidance document and is satisfactory.
The final decision for Riximyo was based on comparative analytical and functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons in two disease settings.
A Notice of Compliance was issued in accordance with the Food and Drug Regulations.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.