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Canada approves trastuzumab biosimilar Kanjinti Posted 30/10/2020

Canada’s medicines regulator, Health Canada, has approved the trastuzumab biosimilar Kanjinti by Amgen. This marks the second trastuzumab biosimilar to be approved by Health Canada.

Kanjinti is produced by Amgen Canada and has been approved for all but one of the indications currently authorized for the Herceptin originator. These relate to the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. However, Kanjinti has not been authorized for use with Perjeta (pertuzumab) and docetaxel for untreated human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer. It has been approved as a 420 mg/vial of powder to be prepared for intravenous administration.

Trastuzumab is a monoclonal antibody treatment for HER2+ breast and gastric cancer. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers [1]. It was developed by Roche/Genentech and given the brand name Herceptin. Patents on Herceptin expired in July 2014 in Europe and in June 2019 in the US [1], allowing biosimilars to enter the markets in these regions.

Kanjinti was authorized for use in the European Union in 2018 [2] and in the US in 2019 [3]. It now joins a host of biosimilars approved in Canada, including three biosimilars of the chimeric monoclonal antibody, rituximab. These are Truxima (approved in 2019) [4], Ruxience and Riximyo (both approved in 2020) [5]. Rituximab can be used for the treatment of rheumatoid arthritis, chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Kanjinti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Kanjinti
4. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar Truxima approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-Truxima-approved-in-Canada
5. GaBI Online - Generics and Biosimilars Initiative. Canada approves rituximab biosimilars Riximyo and Ruxience [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Canada-approves-rituximab-biosimilars-Riximyo-and-Ruxience 

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