Traceability of biopharmaceuticals in spontaneous reporting systems: A cross-sectional study in the FDA adverse event reporting system (FAERS) and eudravigilance databases

Drug Safety

Volumn 36, Issue 8, 2013, Pages 617-625

  Vermeer, Niels S ^a,b   Straus, Sabine M J M ^b,c   Mantel Teeuwisse, Aukje K ^a   Domergue, Francois ^d   Egberts, Toine C G ^a,e   Leufkens, Hubert G M ^a,b   De Bruin, Marie L ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d EUROPEAN MEDICINES AGENCY   (United Kingdom)

^e UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; SMALL MOLECULE TRANSPORT AGENT;

ARTICLE; BATCH PROCESS; CONSUMER ADVOCACY; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; DATA BASE; DRUG APPROVAL; DRUG INFORMATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; MAJOR CLINICAL STUDY; PHARMACEUTICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BIOLOGICAL FACTORS; CROSS-SECTIONAL STUDIES; DATABASES, PHARMACEUTICAL; DRUG LABELING; EUROPE; HUMANS; PRESCRIPTION DRUGS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84881122457     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-013-0073-3     Document Type: Article

References (36)

1. Giezen TJ, Mantel-Teeuwisse AK, Leufkens HG. Pharmacovigilance of biopharmaceuticals: challenges remain. Drug Saf. 2009;32(10):811-7.
2. Declerck PJ. Biotherapeutics in the era of biosimilars: what really matters is patient safety. Drug Saf. 2007;30(12):1087-92.
3. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002;346(7):469-75.
4. Ebbers HC, Mantel-Teeuwisse AK, Moors EH, Schellekens H, Leufkens HG. Today's challenges in pharmacovigilance: what can we learn from epoetins? Drug Saf. 2011;34(4):273-87.
5. Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004;22(11):1383-91.
6. Sharma B. Immunogenicity of therapeutic proteins. Part 3: impact of manufacturing changes. Biotechnol Adv. 2007;25(3):325-31.
7. European Medicines Agency. Note for guidance on biotechnological/ biological products subject to changes in their manufacturing process (CPMP/ICH/5271/03). June 2005. http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500002805.pdf. Accessed 7 May 2013.
8. US FDA. Demonstration of comparability of human biological products, including therapeutic biotechnology-derived products. April 1996. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm122879.htm. Accessed 7 May 2013.
9. Schellekens H. When biotech proteins go off-patent. Trends Biotechnol. 2004;22(8):406-10.
10. Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29(4):310-2.
11. Buttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, et al. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals. 2011;39(2):100-9.
12. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411-9.
13. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov. 2002;1(6):457-62.
14. Walsh G. Biopharmaceutical benchmarks 2010. Nat Biotechnol. 2010;28(9):917-24.
15. Wadman M. Bills target biosimilar drugs. Nature. 2009;458:394-5.
16. McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs. 2011;3(2):209-17.
17. European Medicines Agency. Note for guidance - EudraVigilance human - processing of safety messages and individual case safety reports (ICSRs). 15 October 2010. http://eudravigilance.ema.europa.eu/human/docs/ guid%C2%AFP%C2%AFTechnical%20Documentation%C2%AFEMEA-H-20665-04-en-Final- Revision-2.pdf. Accessed 7 May 2013.
18. US FDA. Postmarketing reporting of adverse experiences. Code of Federal Regulations Title 21 (21 CFR 600.80). Silver Spring: US FDA; 2012.
19. US FDA. Postmarketing reporting of adverse drug experiences, Code of Federal Regulation Title 21, (21 CFR 314.80). Silver Spring: US FDA; 2012.
20. Regulation (EC) No 726/2004 of The European Parliament and of the Council of 31 March 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=OJ:L:2004:136:0001:0033:en:PDF. Accessed 7 May 2013.
21. Crommelin DJA, Storm G, Verrijk R, de Leede L, Jiskoot W, Hennink WE. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm. 2003;266(1-2):3-16.
22. Vonberg RP, Gastmeier P. Hospital-acquired infections related to contaminated substances. J Hosp Infect. 2007;65(1):15-23.
23. Thorpe SJ, Fox BJ, Dolman CD, Lawrence J, Thorpe R. Batches of intravenous immunoglobulin associated with adverse reactions in recipients contain atypically high anti-Rh D activity. Vox Sang. 2003;85(2):80-4.
24. Kurz X, Domergue F, Slattery J, Segec A, Szmigiel A, Hidalgo-Simon A. Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance. Vaccine. 2011;29(26):4378-87.
25. de Bousingen DD. Former French ministers on trial for infected blood-products scandal. Lancet. 1999;353(9153):653.
26. Esmonde TF, Will RG, Slattery JM, Knight R, Harries-Jones R, de Silva R, et al. Creutzfeldt-Jakob disease and blood transfusion. Lancet. 1993;341(8839):205-7.
27. Eaton L. Haemophilia patient had variant CJD agent in spleen. BMJ. 2009;18(338):b705.
28. van Hunsel F, Harmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35(1):45-60.
29. Zuñiga L, Calvo B. Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf. 2010;19(7):661-9.
30. Fox JL. Debate over details of US biosimilar pathway continues to rage. Nat Biotechnol. 2012;30(7):577.
31. Lovis C. Traceability in healthcare: crossing boundaries. Yearb Med Inform. 2008;47(Suppl 1):105-13.
32. O'Dowd A. UK launches inquiry into safety of PIP breast implants. BMJ. 2012;3(344):e11.
33. Petitjean S. Commission to enhance traceability of medical devices. http://www.europolitics.info/commission-to-enhance-traceability-of-medical- devices-art324118.html. Accessed 22 Mar 2012.
34. European Federation of Pharmaceutical Industries and Associations. EFPIA product verification project. April 2011. http://www.efpia.eu. Accessed 16 Jan 2011.
35. Directive 2010/84/EU of The European Parliament and of the Council of 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. http://eudravigilance.ema.europa.eu/human/docs/Directives/dir-2010-84-en.pdf. Accessed 7 May 2013.
36. Hauben M, Reich L, DeMicco J, Kim K. 'Extreme duplication' in the US FDA Adverse Events Reporting System database. Drug Saf. 2007;30(6):551-4.