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Seliverstov E.I.

Russian National Research Medical University named after N.I. Pirogov, Moscow, Russia

Andriiashkin V.V.

Kafedra fakul'tetskoĭ khirurgii im. S.I. Spasokukotskogo Rossiĭskogo gosudarstvennogo meditsinskogo universiteta im. N.I. Pirogova, Moskva

Leont'ev S.G.

Kafedra fakul'tetskoĭ khirurgii im. S.I. Spasokukotskogo Rossiĭskogo gosudarstvennogo meditsinskogo universiteta im. N.I. Pirogova, Moskva

Kirienko A.I.

Russian National Research Medical University nabbed after N.I. Pirogov, Moscow, Russia

Biosimilars analogs of enoxaparin: to what extent is their prescription justified for the treatment of venous thrombosis and pulmonary thromboembolism?

Authors:

Seliverstov E.I., Andriiashkin V.V., Leont'ev S.G., Kirienko A.I.

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Journal: Journal of Venous Disorders. 2013;7(4): 57‑64

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BIOSIMILARS ANALOGS OF ENOXAPARIN: TO WHAT EXTENT IS THEIR PRESCRIPTION JUSTIFIED FOR THE TREATMENT OF VENOUS THROMBOSIS AND PULMONARY THROMBOEMBOLISM?
BIOSIMILARS ANALOGS OF ENOXAPARIN: TO WHAT EXTENT IS THEIR PRESCRIPTION JUSTIFIED FOR THE TREATMENT OF VENOUS THROMBOSIS AND PULMONARY THROMBOEMBOLISM?

To cite this article:

Seliverstov EI, Andriiashkin VV, Leont'ev SG, Kirienko AI. Biosimilars analogs of enoxaparin: to what extent is their prescription justified for the treatment of venous thrombosis and pulmonary thromboembolism? Journal of Venous Disorders. 2013;7(4):57‑64. (In Russ.)

Подписка 2025-2 (Journal of Venous Disorders)
 
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Venous thromboembolism is a challenging problem in modern medicine. Low-molecular weight heparins are the medicines most extensively employed to prevent and treat venous thrombosis and thromboembolism; their effectiveness and safety are fairly well confirmed in multicenter randomized clinical studies. At present, the patent protection of many of these agents including fractionated heparins is about to be lost. It motivated certain pharmaceutical companies to start manufacture of generic low-molecular weight heparins. However, the original formulations and generic medications possess different anticoagulation activity despite their similar structure, physical and chemical properties. That is why, the results of investigations of the original medications can not be extrapolated to their biological analogs. The effectiveness and safety of each generic low-molecular weight heparin need to be confirmed in special clinical studies. The leading world pharmacovigilance organizations adhere to this principle.

Keywords:

venous thromboembolism
low-molecular weight heparins
generics
biological analogs

Authors:

Seliverstov E.I.

Russian National Research Medical University named after N.I. Pirogov, Moscow, Russia

Andriiashkin V.V.

Kafedra fakul'tetskoĭ khirurgii im. S.I. Spasokukotskogo Rossiĭskogo gosudarstvennogo meditsinskogo universiteta im. N.I. Pirogova, Moskva

Leont'ev S.G.

Kafedra fakul'tetskoĭ khirurgii im. S.I. Spasokukotskogo Rossiĭskogo gosudarstvennogo meditsinskogo universiteta im. N.I. Pirogova, Moskva

Kirienko A.I.

Russian National Research Medical University nabbed after N.I. Pirogov, Moscow, Russia

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  2. International Trade Administration. PharmaceuticalIndustryProfile2010 http://ita.doc.gov/td/health/PharmaceuticalIndustryProfile2010.pdf. Доступно 11.06.13
  3. Биоаналоги низкомолекулярных гепаринов: сходство в обмен на эффективность? Клин фармакол и терап 2012; 21: 3: 5-11.  Bioanalogi nizkomolekulyarnykh geparinov: skhodstvo v obmen na effektivnost'? Klin farmakol i terap 2012; 21: 3: 5-11.
  4. Zyryanov K.S., Belousov Yu.B. Original'nye i vosproizvedennye biologicheskie lekarstvennye sredstva: otsenka ekvivalentnosti [Original and reproduced biological medicines: the assessment of equivalence]. Upravlenie zdravookhr 2012; 1: 32.
  5. Walenga J.M., Hoppensteadt D., Cunanan J. et al. Immunogenicity of low molecular weight heparins and their biosimilars. 3rd Workshop on the characterization of heparin products. USP Headquarters: Rockville Maryland (USA) 2009.
  6. Fareed J., Hoppensteadt D., Schulz C. Biochemical and pharmacological heterogeneity in low molecular weight heparins. Impact on the therapeutic profile. Curr Pharm Des 2004; 10: 983-999.
  7. Nugent M. Heparin sequencing brings structure to the function of complex oligosaccharides. Proc Natl Acad Sci USA 2000; 97: 19: 10301-10303.
  8. Turnbull J., Powell A. Heparan sulfate: decoding a dynamic multifunctional cell regulator. Cell Biol 2001; 11: 2: 75-82.
  9. Hirsh J. Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2008; 134: 2: 473.
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  12. Lima M.A., Eduardo H.C. de Farias. Structural and Pharmacological Profile of Generic Enoxaparins Used in Brazil. Clin Appl Thromb Hemost 2012; 18: 4: 379-386.
  13. Walenga J., Jeske W., Hoppensteadt D., Cunanan J., Khan H., Escalante V., Fareed J. Comparative Studies on Branded Enoxaparin and a US Generic Version of Enoxaparin. Clin Appl Thromb Hemost 2013; 19: 3: 261-267.
  14. Fareed J., Bick R. The immunogenic potential of generic version of low-molecular-weight heparins may not be the same as the branded products. Clin Appl Thromb Hemost 2008; 14: 1: 5-7.
  15. FDA US Food and Drug Administration. Establishing Active Ingridient Sameness For A Generic Enoxaparin Sodium a Low Molecular Weight Heparin. Internet available at http://www.fda.gov/drugs/drug safety/postmarket drug safety information for patient sandproviders/ucm220023.htm
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  18. Harenberg J., Kakkar A., Bergqvist D., Barrowcliffe T., Casu B., Fareed J., Mismetti P., Ofosu F.A., Raake W., Samama M., Schulman S. Subcommittee on Control of Anticoagulation of the SSC of the ISTH. Recommendations on biosimilar low-molecular-weight heparins. J Thromb Haemost 2009; 7: 7: 1222-1225.
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  21. Zyryanov S.K. Zaklyuchenie nauchnoy sessii VNOK: Lekarstvennye sredstva biologicheskogo proiskhozhdeniya i ikh analogi [Resolution of the scientific session of the All-Russian Scientific Society of Cardiologists. Medications of biological origin and their analogs]. Ros kardiol zhurn 2012; 2: 94: 15-16.

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