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

Nandurkar, H., Chong, B., Salem, H., Gallus, A., Ferro, V. and McKinnon, R. (2014) Low-molecular-weight heparin biosimilars: potential implications for clinical practice. Internal Medicine Journal, 44 5: 497-500. doi:10.1111/imj.12417


Author Nandurkar, H.
Chong, B.
Salem, H.
Gallus, A.
Ferro, V.
McKinnon, R.
Title Low-molecular-weight heparin biosimilars: potential implications for clinical practice
Journal name Internal Medicine Journal   Check publisher's open access policy
ISSN 1444-0903
1445-5994
Publication date 2014-05-01
Sub-type Article (original research)
DOI 10.1111/imj.12417
Volume 44
Issue 5
Start page 497
End page 500
Total pages 4
Place of publication Richmond, VIC, Australia
Publisher Wiley-Blackwell
Collection year 2015
Language eng
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.
Keyword Biosimilar
Enoxaparin
Heparin
Low-molecular-weight heparin (LMWH)
Venous thromboembolism (VTE)
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Chemistry and Molecular Biosciences
 
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Created: Thu, 22 May 2014, 20:07:27 EST by Mrs Louise Nimwegen on behalf of School of Chemistry & Molecular Biosciences