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Biosimilars of enoxaparin sodium Posted 23/04/2021

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.

The originator product, Lovenox (enoxaparin sodium), made by Sanofi-Aventis, was approved by the US Food and Drug Administration (FDA) in March 1993 [1]. Lovenox had 2019 sales of Euros 1.4 billion due to biosimilar competition in several countries in Europe, see Table 1.

The patents on Lovenox have already expired in both Europe and the US [1]. There are several biosimilars of enoxaparin sodium already approved and others are in development [2], some of which are presented below, see Table 1.

Table 1: Biosimilars of enoxaparin sodium approved or in development

Company name, Country

Product name

Stage of development

Laboratorios ROVI, Spain

Enoxaparin BECAT

Approved in 26 countries in Europe in March 2017 [2].

Amphastar Pharms, France

Enoxaparin Sodium Injection

Approved by FDA in March 2019 [3]

Sandoz Canada, Canada

Inclunox

Approved by Health Canada in November 2020 [4]

Techdow Europe, Sweden

Inhixa

Approved in Europe in September 2016 [2]

Momenta/Sandoz, India/Germany

M-Enoxaparin

Approved by FDA in November 2011 [3]

Sandoz Canada, Canada

Noromby

Approved by Health Canada in November 2020 [4]

Pharmathen, The Netherlands

Thorinane

Approved in Europe in September 2016. Withdrawn from the market in October 2019 [2]

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, agencies including the EMA, FDA and Health Canada have now agreed that enoxaparin sodium should follow the biosimilar pathway [5, 6].

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
5. GaBI Online - Generics and Biosimilars Initiative. Draft revision of biosimilar low molecular weight heparin guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Guidelines/Draft-revision-of-biosimilar-low-molecular-weight-heparin-guideline
6. GaBI Online - Generics and Biosimilars Initiative. Canada clarifies regulatory pathway for subsequent entry low molecular weight heparinswww.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Policies-Legislation/Canada-clarifies-regulatory-pathway-for-subsequent-entry-low-molecular-weight-heparins

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Source: EMA, Health Canada, US FDA

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