Biosimilars of enoxaparin sodium

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 and non-originator biologicals of enoxaparin sodium approved or in development**
Company name, Country	Product name	Stage of development
Amphastar Pharms, France	Enoxaparin Sodium Injection	Approved by FDA in March 2019 [3]
Juno Pharmaceuticals, Australia	Noromby	Approved by Health Canada in November 2020 [4]
Laboratorios ROVI, Spain	Enoxaparin BECAT	Approved in 26 countries in Europe in March 2017 [2].
Momenta/Sandoz, India*/ Germany	M-Enoxaparin	Approved by FDA in November 2011 [3]
Pharmathen, The Netherlands	Thorinane	Approved in Europe in September 2016. Withdrawn from the market in October 2019 [2]
Sandoz Canada, Canada	Inclunox	Approved by Health Canada in November 2020 [4]
Shenzen Techdow Pharmaceutical/ Valeo Pharma, Canada	Redesca	Approved by Health Canada in November 2020 [4]
Techdow Europe, Sweden	Inhixa	Approved in Europe in September 2016 [2]
*See editor’s comment.

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].

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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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