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Biosimilars of low molecular weight heparins: Relevant background information for your drug formulary
Author(s) -
Brouwers Jacobus R.B.J.,
Roeters van Lennep Jeanine E.,
Beinema Maarten J.
Publication year - 2019
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14081
Subject(s) - formulary , biosimilar , medicine , food and drug administration , low molecular weight heparin , guideline , pharmacology , pharmacovigilance , intensive care medicine , drug , thrombosis , surgery , pathology
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.