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 Withdrawn from the market in October 2019 [2]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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| LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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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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