Update of biosimilars approved by Health Canada in 2023

Biosimilars/News | Posted 12/06/2024 post-comment0 Post your comment

Since November 2023, Canada’s drug regulator, Health Canada, has approved no fewer than five biosimilars for the treatment of deep vein thrombosis (DVT), cancer, plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and several serious retinal diseases, such as wet age-related macular degeneration.

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Following the regular updates on biosimilars approved by Health Canada [1], the list of additional biosimilars approved in 2023 continues to grow.
These approvals comprise: 

– Celltrion’s Vegzelma, biosimilar of Hoffmann La Roche’s Avastin (bevacizumab) – authorized on 3 January 2023 [2]

– Baxter’s Axberi and Axberi HP, biosimilars of Sanofi’s Lovenox and Lovenox HP (enoxaparin sodium) – authorized on 27 July 2023

– Teva’s Ranopto, biosimilar of Novartis’s LUCENTIS (ranibizumab) – authorized on 11 October 2023 [3]

– JAMP Pharma’s Jamteki and Amgen’s Wezlana, biosimilars of Janssen’s Stelara (ustekinumab) – authorized on 23 November and 27 December 2023, respectively [3]

The Health Canada authorization of Vegzelma was based on a comprehensive data package of analytical, preclinical and clinical studies, demonstrating that Vegzelma is highly similar to the reference product Avastin in terms of efficacy, safety and pharmacokinetics [2].

Axberi and Axberi HP (enoxaparin sodium) are an antithrombotic agent. Axberi comes in five pre-filled syringe dosages, while Axberi HP is available in two pre-filled syringe dosages, both for subcutaneous or intravenous administration only.

By end of March 2024, Health Canada has approved 59 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor (G-CSF), insulin, monoclonal antibodies and tumour necrosis factor (TNF)-inhibitor, for use in Canada [3].

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LATIN AMERICAN FORUM
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References
1. GaBI Online - Generics and Biosimilars Initiative. Canada approves three more biosimilars in 2022 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 12]. Available from: www.gabionline.net/biosimilars/news/canada-approves-three-more-biosimilars-in-2022
2. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar Vegzelma approved and Aybintio launched in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 12]. Available from: www.gabionline.net/biosimilars/news/bevacizumab-biosimilar-vegzelma-approved-and-aybintio-launched-in-canada
3. GaBI Online - Generics and Biosimilars Initiative. Three more biosimilar approvals in Canada in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 12]. Available from: www.gabionline.net/biosimilars/news/three-more-biosimilar-approvals-in-canada-in-2023
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 12]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-canada

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