title: Low-molecular-weight heparin biosimilars: potential implications for clinical practice. Australian Low-Molecular-Weight Heparin Biosimilar Working Group (ALBW).
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.
authors.affiliation: Department of Medicine and Haematology, The University of Melbourne and St Vincent's Hospital, Melbourne, Victoria, Australia.
authors.forename: H
authors.initials: H
authors.lastname: Nandurkar
authors.forename: B
authors.initials: B
authors.lastname: Chong
authors.forename: H
authors.initials: H
authors.lastname: Salem
authors.forename: A
authors.initials: A
authors.lastname: Gallus
authors.forename: V
authors.initials: V
authors.lastname: Ferro
authors.forename: R
authors.initials: R
authors.lastname: McKinnon
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000925:Anticoagulants / Q000009:adverse effects / Q000737:chemistry / Q000145:classification / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001315:Australia; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001709:Biotechnology; D004311:Double-Blind Method; D017277:Drug Approval; D004345:Drug Industry; D057915:Drug Substitution; D006077:Government Agencies / Q000592:standards; D006495:Heparin, Low-Molecular-Weight / Q000009:adverse effects / Q000737:chemistry / Q000145:classification / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D015394:Molecular Structure; D008970:Molecular Weight; D016032:Randomized Controlled Trials as Topic; D013329:Structure-Activity Relationship; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D000925:Anticoagulants; D059451:Biosimilar Pharmaceuticals; D006495:Heparin, Low-Molecular-Weight
keywords: biosimilar; enoxaparin; heparin; low-molecular-weight heparin (LMWH); venous thromboembolism (VTE)