Canada approves rituximab biosimilars Riximyo and Ruxience

Biosimilars/News | Posted 22/05/2020 post-comment0 Post your comment

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilars Riximyo (GP2013) and Ruxience (PF-05280586) for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

Rituximab V13D29

The drugs are biosimilar of Roche’s Rituxan (rituximab). Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

Sandoz’s Riximyo was approved on 28 April 2020 as a solution for intravenous injection in dosages of 100 mg/10 mL and 500 mg/50 mL. Pfizer’s Ruxience was approved on 4 May 2020 as a 10 mg/mL solution for intravenous injection.

These approvals bring the total rituximab biosimilars approved in Canada up to three. Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries, had its rituximab biosimilar, Truxima (CT P10) approved by Health Canada in April 2019 [1].

The drugs are currently under consideration for public reimbursement by the pan-Canadian Pharmaceutical Alliance for public reimbursement on federal, provincial and territorial drug formularies.

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1. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar Truxima approved in Canada []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from:

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Source: Health Canada

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