Canada approves three more biosimilars in 2022

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Canada approves three more biosimilars in 2022

Biosimilars/News | Posted 28/05/2024 0 Post your comment

Since the last update in June 2022, Health Canada has approved three more biosimilars (Myxredlin, Rymti, Elonox) in 2022 [1].

The biosimilars approved in the second half of 2022 are:

– Baxter’s MYXREDLIN, biosimilar of Novo Nordisk’s NOVOLIN (human insulin, recombinant) – authorized on 3 August 2022
– Lupin Pharma’s RYMTI, biosimilar of Immunex’s ENBREL (etanercept) – authorized on 13 September 2022 [2]
– Fresenius Kabi’s ELONOX and ELONOX HP, biosimilars of Sanofi’s LOVENOX and LOVENOX HP (enoxaparin sodium) – Authorized on 26 October 2022

Myxredlin (insulin human in 0.9% sodium chloride injection) is available in a standardized concentration of 100 units/100 mL in a flexible plastic container indicated to improve glycaemic control in adults and paediatric patients with diabetes mellitus.

Lupin’s Rymti (etanercept) is indicated in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis, and is available as an injectable easy-to-use pre-filled pen and a pre-filled syringe [2].

Elonox (enoxaparin sodium) is the second biosimilar product introduced in Canada by Fresenius Kabi. Elonox and Elonox HP are indicated for deep vein thrombosis and comes in seven pre-filled syringe dosages. All are now available and listed on every provincial formulary across Canada.

The Health Canada authorization of Elonox, was based on the evidence submitted to Health Canada including analytical, and clinical data in healthy volunteers and patients. Indications have been granted on the basis of similarity between the biosimilar and the reference biological drug.

By end of March 2024, Health Canada had 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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References
1. GaBI Online - Generics and Biosimilars Initiative. Canada approves five biosimilars in last seven months [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 28]. Available from: www.gabionline.net/biosimilars/news/canada-approves-five-biosimilars-in-last-seven-months
2. GaBI Online - Generics and Biosimilars Initiative. Canada approves etanercept biosimilar Rymti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 28]. Available from: www.gabionline.net/biosimilars/news/canada-approves-etanercept-biosimilar-rymti
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 28]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-canada

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