PMID- 22274818
OWN - NLM
STAT- MEDLINE
DCOM- 20120719
LR  - 20211021
IS  - 1776-260X (Electronic)
IS  - 1776-2596 (Linking)
VI  - 7 Suppl 1
DP  - 2012 Mar
TI  - Low molecular weight heparin biosimilars: how much similarity for how much 
      clinical benefit?
PG  - S35-42
LID - 10.1007/s11523-011-0194-5 [doi]
AB  - The development of biosimilar versions of low molecular weight heparins (LMWHs) 
      raises real medical concerns. To illustrate this, we have chosen as an example 
      the specific clinical setting of antithrombotic management of acute coronary 
      syndromes (ACS). In this indication, the LMWH enoxaparin has consistently shown 
      its superiority in terms of efficacy when compared to unfractionated heparin 
      (UFH) and in a number of direct or indirect comparisons to other LMWHs. For this 
      reason, enoxaparin has become the gold standard for anticoagulation in 
      cardiology, recommended by practice guidelines and extensively used in everyday 
      practice. We are concerned by the fact that some patients might be treated with a 
      biosimilar copy of enoxaparin, on the basis of simplified criteria that are not 
      specific enough to differentiate between different available LMWHs and are thus 
      unable to differentiate between enoxaparin and a biosimilar. In the absence of 
      evidence from clinical trials, especially in ACS, we believe that it is difficult 
      to ensure that the benefit/risk ratio of enoxaparin and its copy are equivalent. 
      In addition to efficacy, safety issues also have to be taken into consideration, 
      since biosimilars consist of glycan chain mixtures that exhibit specific 
      immunoallergic features. Contamination of raw material with other glycans or 
      xenobiotic material during extraction and fractionation may trigger potentially 
      harmful immune reactions.
FAU - Drouet, Ludovic
AU  - Drouet L
AD  - Angio-hEmatologie et Clinique des Anticoagulants, CREATIF, Hopital Lariboisiere, 
      AP-HP Paris, Faculte de Medecine Paris-VII, Paris, France. 
      ludovic.drouet@lrb.aphp.fr
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20120125
PL  - France
TA  - Target Oncol
JT  - Targeted oncology
JID - 101270595
RN  - 0 (Biological Products)
RN  - 0 (Heparin, Low-Molecular-Weight)
SB  - IM
MH  - Biological Products/*therapeutic use
MH  - Heparin, Low-Molecular-Weight/*pharmacokinetics
MH  - Humans
MH  - Therapeutic Equivalency
MH  - Tissue Distribution
EDAT- 2012/01/26 06:00
MHDA- 2012/07/20 06:00
CRDT- 2012/01/26 06:00
PHST- 2011/07/18 00:00 [received]
PHST- 2011/08/02 00:00 [accepted]
PHST- 2012/01/26 06:00 [entrez]
PHST- 2012/01/26 06:00 [pubmed]
PHST- 2012/07/20 06:00 [medline]
AID - 10.1007/s11523-011-0194-5 [doi]
PST - ppublish
SO  - Target Oncol. 2012 Mar;7 Suppl 1:S35-42. doi: 10.1007/s11523-011-0194-5. Epub 
      2012 Jan 25.