Advances in hematology: Biosimilars: Considerations with low molecular weight heparins

Clinical Advances in Hematology and Oncology

Volumn 8, Issue 3, 2010, Pages 163-167

  Jackson, Craig M ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARDEPARIN; BIOSIMILAR DRUG; DALTEPARIN; ENOXAPARIN; GENERIC DRUG; GLYCOSAMINOGLYCAN; HEPARIN; HEPARIN COFACTOR II; LOW MOLECULAR WEIGHT HEPARIN; TINZAPARIN; UNCLASSIFIED DRUG; ANTICOAGULANT AGENT;

ARTICLE; BLEEDING; COST CONTROL; DRUG ACTIVITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SAFETY; HEALTH CARE COST; HUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; THROMBUS; FOOD AND DRUG ADMINISTRATION; UNITED STATES;

ANTICOAGULANTS; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77950823865     PISSN: 15430790     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (24)

1. Kresse GB. Biosimilars-science, status, and strategic perspective. Eur J Pharm Biopharm. 2009;72:479-486.
2. Emerging Health Care Issues: Follow-on Biologic Drug Competition. Federal Trade Commission Report. June 2009.
3. Johnson JA. FDA regulation of follow-on biologics, CRS Report for Congress, Congressional Research Service, 2007.
4. Jeske WP, Walenga JM, Hoppensteadt DA, et al. Differentiating low-molecular-weight heparins based on chemical, biological, and pharmacologic properties: implications for the development of generic versions of low-molecular-weight heparins. Semin Thromb Hemost. 2008;34:74-85.
5. McAuley DF. The Clinician's Ultimate Reference. Available at: http://www.globalrph.com/lmwh.htm. Accessed February 22, 2010.
6. Center for Business Intelligence. FDA perspectives on the analytical characteriza-tion of follow-on protein products. National Harbor, MD: September 14-15, 2009.
7. European Medicines Agency. Guidelines on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Low-Molec-ular-Weight-Heparins (EMEA/CHMP/BMWP/118264-2007): 2007. London, United Kingdom. European Medicines Agency; 2009.
8. Hollingshead J, Jacoby R. Avoiding no man's land. Potential unintended conse-quences of follow-on biologics. Available at: www.deloitte.com/us/FOB. Accessed February 22, 2010.
9. Shah AB, Martin BS, Rosebush LH. The proposed approval pathway for 'biosimilars' and its potential implications for various stakeholders. Available at: www.ebglaw.com/files/34661_HealthAlertBiosimilars.pdf. Accessed February 22, 2010.
10. USP Heparin Information. Available at http://www.usp.org/hottopics/hepa-rin.html. Accessed February 22, 2010.
11. Innohep (tinzaparin sodium injection). Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm090743.htm. Accessed February 22, 2010.
12. Communication about an ongoing safety review of Innohep (tinzaparin sodium injection). Available at: http://www.fda.gov/Drugs/DrugSafety/Post-marketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformation-forHeathcareProfessionals/ucm136254.htm. Accessed February 22, 2010.
13. Arixtra, Fragmin, Innohep, and Lovenox injection. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm196983.htm. Accessed Febru-ary 22, 2010.
14. Wu CL. Regional anesthesia and anticoagulation. J Clin Anesth. 2001;13:49-51.
15. Kishimoto TK, Viswanathan K, Ganguly T, et al. Contaminated heparin asso-ciated with adverse clinical events and activation of the contact system. N Engl J Med. 2008;358:2457-2467.
16. Harenberg J. LMWH-new mechanisms of action. Thromb Res. 2009;123 Suppl 3:S1-4.
17. Mulloy B, Gee C, Wheeler S, Wait R, Thomas S, Gray E, Barrowcliffe TW. Molecular weight measurements of low molecular weight heparins by gel perme-ation chromatography. Thromb Haemost. 1997;77:668-674.
18. Gray E, Mulloy B. Biosimilar low weight heparin products. J Thromb Haemost. 2009;7:1218-1221.
19. Gray E, Mulloy B, Barrowcliffe TW. Heparin and low-molecular-weight hepa-rin. Thromb Haemost. 2008;99:807-818.
20. Dinwoodey DL, Ansell JE. Heparins, low-molecular-weight heparins, and pentasaccharides: use in the older patient. Cardiol Clin. 2008;26:145-155.
21. Guerrini M, Guglieri S, Casu B, et al. Antithrombin-binding octasaccharides and role of extensions of the active pentasaccharide sequence in the specificity and strength of interaction. Evidence for very high affinity induced by an unusual glucuronic acid residue. J Biol Chem. 2008;283:26662-26675.
22. Verhamme IM, Bock PE, Jackson CM. The preferred pathway of glycosami-noglycan-accelerated inactivation of thrombin by heparin cofactor II. J Biol Chem. 2004;279:9785-9795.
23. EDQM-USP-NIBSC Workshop on the Characterisation of Heparin Products. Accessible at http://www.edqm.eu/medias/fichiers/Session_1_Contamination_of_heparin_Part_2.pdf. Accessed February 22, 2010.
24. Racine E. Differentiation of the Low-Molecular-Weight Heparins. Available at: http://www.medscape.com/viewarticle/438158. Accessed February 22, 2010.