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

Abstract

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.

Keywords: anticoagulant; biosimilar; formulary; generics; low molecular weight heparin.

Figure 1

Synthesis of enoxaparin from heparin with schematic structures. Chains generated from the internal structure of parent heparin chain are the most abundant components. (with permission Elsevier and author: Liu et al. J Chromatography A 2017;1480:32040)