Low-molecular-weight heparin biosimilars: Potential implications for clinical practice

Harshal Hanumant Nandurkar, Beng Hock Chong, Hatem Hassan Salem, Alexander Gallus, Vito Ferro, Ross A McKinnon

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Abstract

A working group of clinicians and scientists was formed to review the clinical considerations for use of low-molecular-weight heparin (LMWH) biosimilars. LMWH are biological molecules of significant complexity; the full complexity of chemical structure is still to be elucidated. LMWH biosimilars are products that are biologically similar to their reference product and rely on clinical data from a reference product to establish safety and efficacy. The complex nature of LMWH molecules means that it is uncertain whether a LMWH biosimilar is chemically identical to its reference product; this introduces the possibility of differences in activity and immunogenicity. The challenge for regulators and clinicians is to evaluate the level of evidence required to demonstrate that a LMWH is sufficiently similar to the reference product. The consensus opinion of the working group is that prior to clinical use a LMWH biosimilar should have proven efficacy and safety, similar to the reference product with prospective studies, which should be confirmed with a proactive post-marketing pharmacovigilance programme.
Original languageEnglish
Pages (from-to)497 - 500
Number of pages4
JournalInternal Medicine Journal
Volume44
Issue number5
DOIs
Publication statusPublished - 2014

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