Regulatory Decision Summary for Truxima

Truxima (rituximab) is a biosimilar biologic drug to the Canadian authorized reference product, Rituxan. Both contain the active pharmaceutical ingredient, rituximab. Rituximab (marketed as Rituxan since 2000) has proven to have a favourable benefit/risk balance for the treatment of patients with non-Hodgkin lymphoma NHL, chronic lymphocytic leukemia (CLL), Rheumatoid Arthritis (RA) as well as several other diseases.

This new drug submission was submitted to support the authorization of Truxima for the treatment of several indications in NHL, CLL, and RA. As clinical support for authorization, the sponsor provided evidence demonstrating the pharmacokinetic similarity of Truxima and Rituxan in patients with advanced follicular lymphoma and rheumatoid arthritis. In addition, clinically meaningful differences in safety and efficacy were not detected in a randomized, controlled, clinical trial comparing Truxima and Rituxan in patients with moderate to severe RA. A descriptive comparison of efficacy, in terms of the overall response rate, did not suggest a difference between products in patients with advanced follicular lymphoma. The results of these studies, in combination with the results of comparative physicochemical and biological assays, provide sufficient evidence of similarity to support the authorization of Truxima for use in treating NHL, CLL and RA. Based on an assessment of the relevant information provided in the submission, Truxima is considered to have a benefit/risk balance similar to that established for the claimed indications for the reference product, Rituxan. Therefore, the benefit/risk balance for Truxima is considered favourable for the treatment of NHL, CLL, and RA as outlined in the approved product monograph.