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Canada approves enoxaparin biosimilars Inclunox and Noromby Posted 20/11/2020

Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Inclunox and Noromby.

The drugs are biosimilars of Lovenox (enoxaparin sodium), made by Sanofi-Aventis. Enoxaparin sodium is an anticoagulant medication (blood thinner). It is used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. It is also used in those with acute coronary syndrome (ACS) and heart attacks.

Sandoz’s Inclunox and Noromby were approved on 5 November 2020 as a solution for either intravenous administration or subcutaneous injection at doses of 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL, 120 mg/0.8 mL and 150 mg/mL. Noromby has also been approved at a dose of 20 mg/0.2 mL.

Enoxaparin sodium is an anticoagulant derived from porcine intestinal mucosa. It was first developed in the 1980s and is classified as a low molecular weight heparin (LMWH). There has previously been debate regarding whether non-originator LMWHs should be classified as generics or biosimilars [1], as generic drugs should by definition be identical to the reference product, but research has shown analytical differences between non-originator and reference LMWHs. However, Health Canada clarified its regulatory pathway for LMWHs back in 2013 [2]. The agency decided that copies of these products should use the pathway for ‘subsequent entry biologics’, essentially categorizing them as biosimilars.

The approval of Inclunox and Noromby mark the first enoxaparin biosimilars to be approved in the country.

Sandoz has four other biosimilars approved in Canada. Omnitrope (somatropin) was approved by Health Canada in April 2009 [3], Erelzi (etanercept) in August 2017 [3], Riximyo (rituximab) in April 2020 [4] and Ziextenzo was approved in April 2020 [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Non-originator low molecular weight heparins: generics or biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/Research/Non-originator-low-molecular-weight-heparins-generics-or-biosimilars 
2. GaBI Online - Generics and Biosimilars Initiative. Canada clarifies regulatory pathway for subsequent entry low molecular weight heparins [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Policies-Legislation/Canada-clarifies-regulatory-pathway-for-subsequent-entry-low-molecular-weight-heparins 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada 
4. GaBI Online - Generics and Biosimilars Initiative. Canada approves rituximab biosimilars Riximyo and Ruxience [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/News/Canada-approves-rituximab-biosimilars-Riximyo-and-Ruxience 
5. GaBI Online - Generics and Biosimilars Initiative. Canada approves pegfilgrastim biosimilar Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/News/Canada-approves-pegfilgrastim-biosimilar-Ziextenzo 

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Source: Health Canada

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