Heparin is an anti-coagulant (blood thinner) used to prevent blood clots in conditions including deep vein thrombosis and in the treatment of heart attacks and angina. LMWH is obtained by fractionation, has an average MW of less than 8,000 Da, and provides more predictable effects than natural, unfractionated heparin.

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.

Back in 2013, Health Canada (the federal department responsible for health in Canada) clarified its regulatory pathway for LMWHs [2], stating that copies of these products should use the pathway for ‘subsequent entry biologics’, essentially categorizing them as biosimilars.

It has now been announced that Valeo Pharma, a Canadian company based in Quebec, had signed a licensing agreement with an international manufacturer giving them the exclusive rights to register, distribute and market an LMWH biosimilar in Canada.

This could be a significant boost for the company, as total sales of LMWHs exceeded CA$200 million in 2018. If successful it would be the first LMWH biosimilar to reach the Canadian market (so far no LMWH biosimilars have been approved by Health Canada).

CEO of Valeo, Steve Saviuk, commented: ‘This licensing agreement provides us with the opportunity to be the first LMWH biosimilar to enter the market’. He added that it would expand the company’s growing portfolio of ‘hospital specialty’ drugs and could be ‘transformational’ for the company.

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Immunogenicity of biosimilar low molecular weight heparins

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 2019 Aug 30]. 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 2019 Aug 30]. Available from: www.gabionline.net/Policies-Legislation/Canada-clarifies-regulatory-pathway-for-subsequent-entry-low-molecular-weight-heparins

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