Biosimilars of low molecular weight heparins: Relevant background information for your drug formulary.

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Clinical Guidelines
Authored By
Brouwers JRBJ, Roeters van Lennep JE, Beinema MJ
Authored On
Interests
Emergency Medicine
Speciality
Emergency Medicine
Book Detail
volume
85
ISSN
1365-2125
No. of pages
8
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ISSN
1365-2125 ; Electronic
IS_Ebsco
true
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Additional Info
["Brouwers JRBJ, Roeters van Lennep JE, Beinema MJ","Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE","Journal Article; Review","2019-11-01","British journal of clinical pharmacology [Br J Clin Pharmacol] 2019 Nov; Vol. 85 (11), pp. 2479-2486. Date of Electronic Publication: 2019 Sep 04.","English","1365-2125","Practice Guidelines as Topic*, Anticoagulants\/*standards , Biosimilar Pharmaceuticals\/*standards , Enoxaparin\/*standards , Thrombosis\/*drug therapy, Anticoagulants\/administration & dosage ; Anticoagulants\/adverse effects ; Biosimilar Pharmaceuticals\/administration & dosage ; Biosimilar Pharmaceuticals\/adverse effects ; Drug Approval\/legislation & jurisprudence ; Enoxaparin\/administration & dosage ; Enoxaparin\/adverse effects ; Europe ; Humans ; Thrombocytopenia\/chemically induced ; Thrombocytopenia\/prevention & control ; United States ; United States Food and Drug Administration\/legislation & jurisprudence ; United States Food and Drug Administration\/standards","Anticoagulants administration & dosage, Anticoagulants adverse effects, Biosimilar Pharmaceuticals administration & dosage, Biosimilar Pharmaceuticals adverse effects, Drug Approval legislation & jurisprudence, Enoxaparin administration & dosage, Enoxaparin adverse effects, Europe, Humans, Thrombocytopenia chemically induced, Thrombocytopenia prevention & control, United States, United States Food and Drug Administration legislation & jurisprudence, United States Food and Drug Administration standards, Anticoagulants standards, Biosimilar Pharmaceuticals standards, Enoxaparin standards, Practice Guidelines as Topic, Thrombosis drug therapy","British journal of clinical pharmacology","85"]
Description
Biosimilars of low molecular weight heparins (LMWHs) are more alike the originator than different branded LMWHs. The latter differ largely in molecular weight, anti-FXa/anti-FIIa ratio and antithrombin binding. The Food and Drug Administration and European Medicines Agency guidelines are sufficient for the clinical use of high quality LMWHs. However, the Food and Drug Administration guideline lacks the results of a phase I clinical trial in the approval process. Most information about biosimilars is available for enoxaparin given that many biosimilars of enoxaparin have received market access. The guidelines of many International Thrombosis Societies for LMWH biosimilars are too stringent, not updated and impractical for formulary uptake discussions. This review gives background information on critical factors for the formulary uptake process of LMWHs with special attention for the use of the System of Objectified Judgment Analysis/Infomatrix model.<br /> (© 2019 The British Pharmacological Society.)
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