Update on Brazilian biosimilar enoxaparins

References

• Weitz JI. Low-molecular-weight heparins. N Engl J Med. 1997;337:688–698.
   PubMed Web of Science ®Google Scholar
• Bisio A, Vecchietti D, Citterio M, et al. Structural features of low-molecular-weight heparins affecting their affinity to antithrombin. Thromb Haemost. 2009;102:865–873.
   PubMed Web of Science ®Google Scholar
• Glauser BF, Vairo BC, Oliveira CP, et al. Generic versions of enoxaparin available for clinical use in Brazil are similar to the original drug. J Thromb Haemost. 2011;9:1419–1422.
   PubMed Web of Science ®Google Scholar
• Tapson VF, Decousus H, Pini M, et al. Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients: findings from the international medical prevention registry on venous thromboembolism. Chest. 2007;132:936–945.
   PubMed Web of Science ®Google Scholar
• Merli GJ, Groce JB. Pharmacological and clinical differences between low-molecular-weight heparins: implications for prescribing practice and therapeutic interchange. Pharm Ther. 2010;35(2):95–105.
   Google Scholar
• Vats V, Nutescu EA, Theobald JC, et al. Survey of hospitals for guidelines, policies, and protocols for anticoagulants. Am J Health Syst Pharm. 2007;64:1203–1208.
   PubMed Web of Science ®Google Scholar
• Gray E, Mulloy B, Barrowcliffe TW. Heparin and low-molecular-weight-heparin. Thromb Haemost. 2008;99:807–818.
   PubMed Web of Science ®Google Scholar
• Ofosu FA. The United States and drugs administration approves a generic enoxaparin. Clin Appl Thromb Hemost. 2011;17:5–8.
   PubMed Web of Science ®Google Scholar
• Câmara de Regulação de Mercado de Medicamentos – CMED. Brasília: Agencia Nacional de Vigilância Sanitária, 2016 [cited Aug 26, 2016]. Available from: http://portal.anvisa.gov.br/documents/374947/2829072/LISTA+CONFORMIDADE_2016-07-21.pdf/d9602da5-adae-41bc-9bee-0ed59e001f33
   Google Scholar
• Consulta a Produtos Regularizados. Brasília: Agencia Nacional de Vigilância Sanitária, 2016 [cited Aug 26, 2016]. Available from: http://www7.anvisa.gov.br/datavisa/Consulta_Produto/rconsulta_produto_detalhe.asp
   Google Scholar
• Jeske W, Walenga JM, Hoppensteadt D, et al. Update on the safety and bioequivalence of biosimilars—focus on enoxaparin. Drug Healthc Patient Saf. 2013;10:133–141.
   Google Scholar
• Drouet L. Low molecular weight heparin biosimilars: how much similarity for how much clinical benefit? Targ Oncol. 2012;7(Suppl 1):S35–S42.
   PubMed Web of Science ®Google Scholar
• Lima MA, Farias EHC, Ruddb TR, et al. Low molecular weight heparins: structural by spectroscopic and multivariate approaches. Carbohydr Polym. 2011;85:903–909.
   Web of Science ®Google Scholar
• Mourier PA, Agut C, Souaifi-Amara H, et al. Analytical and statistical comparability of generic enoxaparins from the US market with the originator product. J Pharm Biomed Anal. 2015;115:431–442.
   PubMed Web of Science ®Google Scholar
• Guerrini M, Rudd TR, Mauri L, et al. Differentiation of generic enoxaparins marketed in the United States by employing NMR and multivariate analysis. Anal Chem. 2015;87:8275–8283.
   PubMed Web of Science ®Google Scholar
• Harenberg J, Kakkar A, Bergqvist D, et al. Recommendations on biosimlar low-molecular-weight heparins. J Thromb Haemost. 2009;7:1222–1225.
   PubMed Web of Science ®Google Scholar
• FDA response to Citizen Petition. Docket No. FDA-2003-P-0273, Washington (DC): US Food and Drug Administration, 2010 [cited Apr 5, 2016]. Available from: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM220083.pdf
   Google Scholar
• United States Pharmacopeia. Enoxaparin sodium injection monograph. Rockville: United States Pharmacopeia 35; 2012. p. 5471–5473.
   Google Scholar
• European Pharmacopoeia. Low-molecular-weight heparin monograph. Strasbourg: European Pharmacopoeia 7.0; 2011. p. 2151–2153.
   Google Scholar
• Brazilian Pharmacopeia. Heparina de Baixo peso molecular.5th ed. Brasília: Farmacopéia Brasileira;2010 Suppl 1.p. 69–73.
   Google Scholar
• Glauser BF, Vairo BC, Oliveira SN, et al. Structure and haemostatic effects of generic versions of enoxaparin available for clinical use in Brazil: similarity to the original drug. Thromb Haemost. 2012;107:302–314.
   PubMed Web of Science ®Google Scholar
• Oliveira SN, Santos GR, Glauser BF, et al. Structural and functional analyses of biosimilar enoxaparins available in Brazil. Thromb Haemost. 2015;113:53–65.
   PubMed Web of Science ®Google Scholar
• Olson ST, Björk I, Shore JD. Kinetic characterisation of heparin-catalysed and uncatalysed inhibition of blood coagulation proteinases by antithrombin. Methods Enzymol. 1993;222:525–559.
   PubMed Web of Science ®Google Scholar
• Wessler S, Reimer SM, Sheps MC. Biologic assay of a thrombosis-inducing activity in human serum. J Appl Physiol. 1959;14:943–946.
   PubMed Web of Science ®Google Scholar
• Collignon F, Frydman A, Caplain H, et al. Comparison of the pharmacokinetic profiles of three low molecular mass heparin – dalteparin, enoxaparin and nadroparin – administered subcutaneously in healthy volunteers (dose for prevention of thromboembolism). Thromb Haemost. 1995;73:630–640.
   PubMed Web of Science ®Google Scholar
• Guideline on similar biological medicinal products containing low-molecular-weight-heparins. London: European Medicine Agencies, 2008 [cited Apr 5, 2016]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500003928.pdf
   Google Scholar
• Guia para realização de estudos clínicos e não clínicos para registro de heparinas como produtos biológicos pela via da comparabilidade. Brasília: Agencia Nacional de Vigilância Sanitária, 2011 [cited Apr 5, 2016]. Available from: http://portal.anvisa.gov.br/wps/wcm/connect/fdd0d20048bd2217a789af9a6e94f0d0/heparina.pdf
   Google Scholar
• Pharmacy Program. Jefferson City: Missouri Departament of Social Services, 2016 [cited Aug 21, 2016]. Available from: https://dss.mo.gov/mhd/cs/pharmacy/pdf/macspec.pdf
   Google Scholar
• Harenberg J, Walenga J, Torri G, et al. Update of the recommendations on biosimilar low-molecular-weight heparins from the scientific subcommittee on control of anticoagulation of the international society on thrombosis and haemostasis. J Thromb Haemost. 2013;11:1421–1425.
   PubMed Web of Science ®Google Scholar
• Casella IB, Puech-Leão P. Generic versus branded enoxaparin in prophylaxis and treatment of vein thrombosis. Rev Assoc Med Bras. 2015;61:44–50.
   PubMed Web of Science ®Google Scholar
• Boubaker H, Grissa M, Sassi M, et al. Generic and branded enoxaparin bioequivalence: a clinical and experimental study. J Bioequiv Availab. 2015;7:225–228.
   Google Scholar
• Tan X, Cui H. Comparative studies on biological activity of generic and branded enoxaparin in vivo and vitro. Blood Coagul Fibrinolysis. 2015;26:805–810.
   PubMed Web of Science ®Google Scholar
• Walenga JM, Jeske WP, Hoppensteadt D, et al. Comparative studies on branded enoxaparin and a US generic version of enoxaparin. Clin Appl Thromb Hemost. 2013;19:261–267.
   PubMed Web of Science ®Google Scholar
• Walenga JM, Jeske WP, Escalante V, et al. Thromboelastographic evaluation of blood coagulation in the presence of branded and generic enoxaparins. Int Angiol. 2012;31:517–525.
   PubMed Web of Science ®Google Scholar
• Jeske W, Litinas E, Khan H, et al. A comparison of the pharmacodynamic behavior of branded and biosimilar enoxaparin in primates. Clin Appl Thromb Hemost. 2012;18:294–298.
   PubMed Web of Science ®Google Scholar
• Gomes M, Ramacciotti E, Henriques AC, et al. Generic versus branded enoxaparin in the prevention of venous thromboembolism following major abdominal surgery: report of an exploratory clinical trial. Clin Appl Thromb Hemost. 2011;17:633–639.
   PubMed Web of Science ®Google Scholar
• Feng L, Shen-Tu J, Liu J, et al. Bioequivalence of generic and branded subcutaneous enoxaparin: a single-dose, randomized-sequence, open-label, two-period crossover study in healthy Chinese male subjects. Clin Ther. 2009;31:1559–1567.
   PubMed Web of Science ®Google Scholar
• Zuin M, Picariello C, Marcantoni L, et al. Burden of costs associated with heparin-induced thrombocytopenia: is time to remove unfractionated heparin from the drug formularies in medical institutions? Ann Transl Med. 2016 Jun;4(12):244.
   PubMed Web of Science ®Google Scholar