Regulatory Decision Summary for Ruxience

Ruxience was developed as a biosimilar to the Canadian reference biologic drug, Rituxan (rituximab).

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 biofunctional assays were also conducted as part of the analytical comparability package.

The clinical development program consisted of 2 pivotal studies:

• A pharmacokinetic (PK) study in patients with rheumatoid arthritis who had inadequate disease control on at least 1 prior anti-TNF treatment. 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 pharmacokinetic study also provided supportive evidence of similarity, between Ruxience and the reference product, in safety and efficacy.
• The pivotal comparative clinical efficacy and safety study was conducted among patients with low tumour burden follicular lymphoma. The primary efficacy analysis demonstrated that the 95% CI of the risk difference of the objective response rates (ORR) was contained within the pre-defined interval of -16% to 16%. Secondary endpoints were supportive of the primary results, and the safety profiles were considered comparable.

A scientific rationale, provided to support the authorization of Ruxience in the proposed indications held by the reference product Rituxan, was considered in accordance with Health Canadas biosimilar guidance document, and is satisfactory.

The biosimilarity of Ruxience to Rituxan was established based on comparative analytical and functional, non-clinical, pharmacokinetic (PK), and clinical studies.

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.