Canada approves rituximab biosimilar Riabni

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Canada approves rituximab biosimilar Riabni

Biosimilares/Novedades | Posted 09/07/2021 0 Post your comment

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilar Riabni for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

The drug is a 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.

Amgen’s Riabni (ABP 798) was approved on 11 March 2021 as a solution for intravenous injection at a dose of 10 mg/mL.

This latest approval brings the total rituximab biosimilars approved in Canada up to four.

Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries, had its rituximab biosimilar, Truxima (CT P10), approved by Health Canada in April 2019 [1]. This is the first rituximab biosimilar approved in Canada. This was followed in April 2020 by Sandoz’s Riximyo and in May 2020 by Pfizer’s Ruxience.

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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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 9]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-canada

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Source: Health Canada