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.
Canada approves rituximab biosimilars Riximyo and Ruxience
Biosimilars/News
|
Posted 22/05/2020
0
Post your comment
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.
Related articles
Biosimilars of rituximab
Biosimilars approved in Canada
Reference
1. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar Truxima approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-Truxima-approved-in-Canada
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.
Source: Health Canada
Research
Reaching ESG goals in pharmaceutical development
What is the future for the US biosimilar interchangeability designation
General
Samsung Bioepis wins Pyzchiva case; Regeneron patent rulings threaten foreign biosimilars
Chinese biosimilars go global: growth, partnerships, and challenges
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
EMA recommends approval for insulin glargine biosimilar Ondibta and denosumab biosimilar Osqay
FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus
FDA approves aflibercept biosimilar Eydenzelt and label expansion for adalimumab biosimilar Yuflyma
ANVISA approves biosimilars for denosumab, trastuzumab, and aflibercept
EMA recommends approval for insulin glargine biosimilar Ondibta and denosumab biosimilar Osqay
Biosimilars/News Posted 16/01/2026
FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus
Biosimilars/News Posted 07/01/2026
FDA approves aflibercept biosimilar Eydenzelt and label expansion for adalimumab biosimilar Yuflyma
Biosimilars/News Posted 05/12/2025
ANVISA approves biosimilars for denosumab, trastuzumab, and aflibercept
Biosimilars/News Posted 05/12/2025
The best selling biotechnology drugs of 2008: the next biosimilars targets
Post your comment