Canada approves trastuzumab biosimilar Kanjinti

Biosimilares/Novedades | Posted 30/10/2020 post-comment0 Post your comment

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.

Canada V16A15

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.

Related articles
Clinical trials for trastuzumab biosimilars

Biosimilars approved in Canada

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 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
La FDA aprueba el biosimilar pegfilgrastim Stimufend
Approved-V13G05
Biosimilares/Novedades Posted 07/10/2022
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010