Canadian pharmaceuticals firm Valeo Pharma (Valeo) announced on 9 December 2020 that Canada’s drug regulator, Health Canada, had approved its low molecular weight heparin (LMWH) biosimilars Redesca and Redesca HP.
LMWHs are complex anticoagulants derived from porcine intestinal mucosa and are used in the treatment of deep vein thrombosis and pulmonary embolism. There has previously been debate regarding whether non-originator LMWHs should be classified as generics or biosimilars, as generic drugs should by definition be identical to the reference product, but research has shown analytical differences between non-originator and reference LMWHs [1]. Canada clarified its position on LMWHs back in 2013 when it issued a policy statement, which said that similar drugs containing LMWHs should use the biosimilar pathway [2].
Redesca and Redesca HP are the first LMWH biosimilars to be approved by Health Canada [3]. According to Valeo, total Canadian sales of LMWHs exceeded CA$200 million in 2018.
Steve Saviuk, President and CEO of Valeo said that ‘the regulatory approval of Redesca is a significant corporate milestone for Valeo and also great news for the Canadian healthcare system. Mandatory use of biosimilars is increasingly being adopted across the country and is expected to help provide significant savings to provincial healthcare plans.’
Valeo has licensed the LMWHs from Shenzhen Techdow Pharmaceuticals [4], which the company says is ‘the world’s largest Heparin manufacturer’.
The company also stated in its press release that ‘in addition to being used primarily for treating and preventing deep vein thrombosis and pulmonary embolism, LMWH are also now increasingly used as a first line of defence tool in the fight against COVID-19. The World Health Organization’s issued guidance regarding the prophylaxis use of LMWH to help prevent complications in the clinical management of severe acute respiratory infections when novel coronavirus (COVID-19) infection is suspected’.
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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 2021 Jan 22]. 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 2021 Jan 22]. 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 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
4. GaBI Online - Generics and Biosimilars Initiative. Heparin biosimilar to be marketed in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/News/Heparin-biosimilar-to-be-marketed-in-Canada
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