Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of ThorinaneÃ?® and InhixaÃ?®,\nbiosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from\nthe guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on\nThrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic\nequivalence should be demonstrated in at least one adequately designed clinical trial. Shortly after enoxaparin biosimilars\napproval, EMA published a revised version of its guideline, no longer requiring the execution of a clinical study in patients\nat risk of venous thromboembolism.\nAlso the assessment of safety shows some relevant flaws, as it relies only on a 20 healthy volunteers study, clearly\nunderpowered to draw any conclusions about the safety profile of the drug.\nIn our opinion, the approach taken by EMA for approval of enoxaparin biosimilars raises serious concerns about their\nactual, clinical ââ?¬Å?similarityââ?¬Â.\nOn these grounds, with the endorsement of the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian\nSociety for Angiology and Vascular Medicine (SIAPAV), we elaborated the present document aimed at reviewing and\nreappraising some critical points regarding the introduction of biosimilars of LMWH in Europe.\nMoreover, we would strongly advise the Italian National Health Authorities not to entrust safety assessment to the\npost-marketing surveillance only, but to promote well designed and powered studies aimed at establish the actual\nefficacy and safety of LMWH biosimilars.
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