Biosimilars of low‐molecular‐weight heparin products: fostering competition or reducing ‘biodiversity’?

Summary The term ‘biosimilars’ is used to qualify products developed to be similar to an original biological drug. Biosimilars are much more complicated to develop than a generic version of small‐molecule drugs and this is especially true for low‐molecular‐weight heparins (LMWHs). Evidence on the an...

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Bibliographic Details
Published in:Journal of thrombosis and haemostasis 2016-03, Vol.14 (3), p.421-426
Main Authors: Harenberg, J., Cimminiello, C., Agnelli, G., Di Minno, G., Polo Friz, H., Prandoni, P., Scaglione, F.
Format: Article
Language:English
Subjects:
Acute coronary syndromes
Angina pectoris
Anticoagulants - adverse effects
Anticoagulants - economics
Anticoagulants - pharmacokinetics
Biodiversity
Biological products
biosimilar pharmaceuticals
Biosimilar Pharmaceuticals - adverse effects
Biosimilar Pharmaceuticals - economics
Biosimilar Pharmaceuticals - pharmacokinetics
Drug Costs
Drug Discovery - economics
Drug Discovery - methods
Drug Industry - economics
Economic Competition
evidence‐based practise
Heart attacks
Heparin, Low-Molecular-Weight - adverse effects
Heparin, Low-Molecular-Weight - economics
Heparin, Low-Molecular-Weight - pharmacokinetics
Humans
low‐molecular‐weight heparin
Male
Patient Safety
Risk Assessment
Risk Factors
Therapeutic Equivalency
venous thromboembolism
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Summary:Summary The term ‘biosimilars’ is used to qualify products developed to be similar to an original biological drug. Biosimilars are much more complicated to develop than a generic version of small‐molecule drugs and this is especially true for low‐molecular‐weight heparins (LMWHs). Evidence on the antithrombotic management of acute coronary syndromes (ACS) showed that the introduction into the market of biosimilars approved on the basis of simple biological criteria, without robust data from comparative clinical trials, may be hazardous. Moreover, the mixtures of LMWH polysaccharide chains, some immunoallergic properties and potential contamination during the extraction process raise safety concerns. As was the case for the biosimilar erythropoietin, there is the risk that only copies of the most commercially successful LMWHs will be marketed, thus jeopardizing the ‘biodiversity’ now ensured by the presence of several LMWHs, each with unique features that support the use of an individual LMWH as first‐choice therapy in certain categories of patients.
ISSN:1538-7933
1538-7836
1538-7836
DOI:10.1111/jth.13237