684
Views
12
CrossRef citations to date
0
Altmetric
Original Research

Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars

, PhD, , PhD MPH, , MD, , PharmD BCOP, , PhD & , PhD MPH

Bibliography

  • Kozlowski S, Woodcock J, Midthun K, Sherman RB. Developing the nation’s biosimilars program. N Engl J Med 2011;365:385-8
  • Biologics Price Competition and Innovation Act of 2009. 2009. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf [Last accessed 18 February 2014]
  • US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. Rockville, MD; 2012. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf [Last accessed 27 December 2014]
  • Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin 2012;28:1053-8
  • Zuniga L, Calvo B. Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf 2010;19:661-9
  • Felix T, Johansson TT, Colliatie JA, et al. Biologic product identification and US pharmacovigilance in the biosimilars era. Nat Biotechnol 2014;32:128-30
  • Giezen TJ, Mantel-Teeuwisse AK, Leufkens HG. Pharmacovigilance of biopharmaceuticals: challenges remain. Drug Saf 2009;32:811-17
  • FDA Adverse Event Reporting System (FAERS) (formerly AERS). 2012. Available from: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm [Last accessed 5 June 2014]
  • US Food and Drug Administration. Code of Federal Regulations 21CFR600.80: postmarketing reporting of adverse experiences, 2013. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=600.80 [Last accessed 1 July 2014]
  • Booz Allen Hamilton. Evaluation of potential data sources for the FDA Sentinel Initiative – final report. Rockville, MD; 2010. Report No.: US Food and Drug Administration Contract No. HHSF223200831321P. Available from: http://www.regulations.gov/#!documentDetail;D=FDA-2009-N-0192-0017 [Last accessed 27 December 2014]
  • Background about mini-sentinel program, 2010. Available from: www.mini-sentinel.org/about_us/ [Last accessed 5 June 2014]
  • Lietzan EF, Sim LE, Alexander EA. Biosimilar naming: how do adverse event reporting data support the need for distinct nonproprietary names for biosimilars? Food Drug Policy Forum 2013;3:1-24
  • Lovenox (enoxaparin). Full Prescribing Information. Sanofi-Aventis; Bridgewater, NJ; 2013
  • US Food and Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations, 2014. Available from: http://www.accessdata.fda.gov/scripts/cder/ob/docs/queryai.cfm [Last accessed 1 July 2014]
  • Arnold DM, Lim W. A rational approach to the diagnosis and management of thrombocytopenia in the hospitalized patient. Semin Hematol 2011;48:251-8
  • Shantsila E, Lip GY, Chong BH. Heparin-induced thrombocytopenia. A contemporary clinical approach to diagnosis and management. Chest 2009;135:1651-64
  • Arepally GM, Ortel TL. Clinical practice. Heparin-induced thrombocytopenia. N Engl J Med 2006;355:809-17
  • European Medicines Agency. Guide on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins. London, UK; 2013. Report No.: EMEA/CHMP/BMWP/118264/2007 Rev. 1. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500138309.pdf [Last accessed 27 December 2014]
  • Ofosu FA. A review of the two major regulatory pathways for non-proprietary low-molecular-weight heparins. Thromb Haemost 2012;107:201-14
  • US Food and Drug Administration. Guidance for industry: biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. Rockville, MD; 2012. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273001.pdf [Last accessed 27 December 2014]
  • Miller S. Is it necessary to depart from international naming conventions for biosimilars in the US to ensure the safety of biologic and biosimilar therapeutics?: A response to ‘It’s all about the name: what is the imperative of adopting unique names for biologic and biosimilar therapeutics?’. Food and Drug Policy Forum 2013;3:1-24
  • Kwo EC, Kamat P, Steinman MA. Physician use of brand versus generic drug names in 1993-1994 and 2003-2004. Ann Pharmacother 2009;43:459-68
  • Steinman MA, Chren MM, Landefeld CS. What’s in a name? Use of brand versus generic drug names in United States outpatient practice. J Intern Med 2007;22:645-8
  • European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London, UK: 2006. February 22. Report No.: EMEA/CHMP/BMWP/42832/2005. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf [Last accessed 27 December 2014]
  • Ebbers HC, Crow SA, Vulto AG, Schellekens H. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 2012;30:1186-90
  • Kresse GB. Biosimilars – science, status, and strategic perspective. Eur J Pharm Biopharm 2009;72:479-86

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.