Document Detail


US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins.
MedLine Citation:
PMID:  22234748     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Low-molecular-weight heparins (LMWHs) have shown equivalent or superior efficacy and safety to unfractionated heparin as antithrombotic therapy for patients with acute coronary syndromes. Each approved LMWH is a pleotropic biological agent with a unique chemical, biochemical, biophysical and biological profile and displays different pharmacodynamic and pharmacokinetic profiles. As a result, LMWHs are neither equipotent in preclinical assays nor equivalent in terms of their clinical efficacy and safety. Previously, the US Food and Drug Administration (FDA) cautioned against using various LMWHs interchangeably, however recently, the FDA approved generic versions of LMWH that have not been tested in large clinical trials. This paper highlights the bio-chemical and pharmacological differences between the LMWH preparations that may result in different clinical outcomes, and also reviews the implications and challenges physicians face when generic versions of the original/innovator agents are approved for clinical use.
Authors:
Marc Cohen; Walter P Jeske; Jose C Nicolau; Gilles Montalescot; Jawed Fareed
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-1-11
Journal Detail:
Title:  Journal of thrombosis and thrombolysis     Volume:  -     ISSN:  1573-742X     ISO Abbreviation:  -     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-1-11     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9502018     Medline TA:  J Thromb Thrombolysis     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Division of Cardiology, Newark Beth Israel Medical Center, 201 Lyons Avenue, Newark, NJ, 07112, USA, marcohen@barnabashealth.org.
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