Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries, announced on 10 April 2019 that Health Canada had approved its rituximab biosimilar Truxima. This marks the first rituximab biosimilar to be approved by the Canadian medicines’ regulator.
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.
Truxima is a biosimilar to Roche's Rituxan (rituximab). It has been approved in Canada for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis.
The positive decision by Health Canada was based on a review of a comprehensive data package that included analytical characterization, non-clinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data. Teva Canada says that ‘the totality of evidence submitted for Truxima demonstrated that Truxima and Rituxan are highly similar and there were no clinically meaningful differences in safety and efficacy between Truxima and Rituxan for the approved indications.
Truxima (CT P10), which has been developed in collaboration with Korea-based Celltrion, was approved in South Korea in 2016 [1]. The product was also approved in Europe in February 2017 [2] and in the US in November 2018 [3]. The US Food and Drug Administration (FDA), however, has only approved Truxima for non-Hodgkin lymphoma [4]. In the European Union, the biosimilar is approved for the treatment of chronic lymphocytic leukaemia, granulomatosis with polyangiitis, microscopic polyangiitis, non-Hodgkin’s lymphoma and rheumatoid arthritis [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-South-Korea
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-rituximab-biosimilar-Truxima
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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