Identifying and quantifying the accuracy of product name attribution of US-sourced adverse event reports in MedWatch of somatropins and insulins

Therapeutic Innovation and Regulatory Science

Volumn 49, Issue 5, 2015, Pages 706-716

  Stergiopoulos, Stella ^a   Brown, Carrie A ^a   Grampp, Gustavo ^b   Felix, Thomas ^b   Getz, Kenneth A ^a  

^a TUFTS UNIVERSITY   (United States)

^b AMGEN INC   (United States)

Author keywords

Biosimilar; FAERS; FDA Adverse Event Reporting System; FDA MedWatch; Pharmacovigilance

Indexed keywords

HUMAN GROWTH HORMONE; HUMAN INSULIN; INSULIN DERIVATIVE;

ACCURACY; ARTICLE; DRUG LABELING; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL;

EID: 84946014289     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479015578156     Document Type: Article

References (29)

1. Food and Drug Administration. Biologics Price Competition and Innovation Act of 2009. Washington, DC: Food Drug Administration; 2009.
2. Grabowski HG, Guha R, Salgado M. Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future. Health Aff. 2014;33(6):1048-1057.
3. Pro Pharma Communications International. FDA Accepts Biosimilar Filgrastim Application: Generics and Biosimilars Initiative. Mol, Belgium: Pro Pharma Communications International; 2014.
4. Felix T, Johansson TT, Colliatie JA, Goldberg MR, Fox AR. Biologic product identification and US pharmacovigilance in the biosimilars era. Nat Biotech. 2014;32(2):128-130.
5. Pro Pharma Communications International. Hospira Submits Application to FDA for Epoetin Alfa Biosimilar. Mol, Belgium: Pro Pharma Communications International; 2015.
6. Pro Pharma Communications International. Apotex Pegfilgrastim Biosimilar Under FDA Review. Mol, Belgium: Pro Pharma Communications International; 2015.
7. Gaffney A. Sandoz First Company to File for Biosimilar Approval in US Under New Pathway. Rockville, MD: Regulatory Affairs Professionals Society; 2014.
8. Fitton PR. Comments of Amgen Inc on GPhA and Novartis’s Citizen Petitions Requesting Identical Non-proprietary Names for Biological Products and Their Respective Reference Products Docket Nos FDA-2013-P-1153; FDA-2013-P-1398, Respectively. Thousand Oaks, CA: Amgen; 2013.
9. Carroll J. Manufacturers square off over naming of biosimilars. http://www.managedcaremag.com/linkout/2013/12/6. Published December 2013.
10. Fitton J. Biosimilar naming decision nears as applications arrive at FDA: the PRM report 2014. https://www.pharmamedtechbi.com/publications/rpm-report/10/9/biosimilar-naming-decisionnears-as-applications-arrive-at-fda. Accessed October 9, 2014.
11. Casadevall N, Felix T, Strober B, Warnock D. Similar names for similar biologics. BioDrugs. 2014;28(5):439-444.
12. Karlin S. Remicade biosimilar from celltrion includes bridging, extrapolation and switching data. https://www.pharmamedtechbi.com/publications/the-pink-sheet-daily/2014/8/11/emremicadeem-biosimilar-from-celltrion-includes-bridging-extrapolation-and-switching-data. Published August 11, 2014.
13. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Guideline on Similar Biological Medicinal Products. London, England: European Medicines Agency; 2005.
14. Kozlowski S, Woodcock J, Midthun K, Behrman Sherman R. Developing the nation’s biosimilars program. N Engl J Med. 2011;365(5):385-388.
15. Medicines and Healthcare Products Regulatory Agency. Drug safety update: biosimilar products. http://www.mhra.gov.uk/Safe-tyinformation/DrugSafetyUpdate/CON084739. Published February 2008. Accessed October 9, 2014.
16. European Union. Directives: Commission Implementing Directive 2012/52/EU of 20 December 2012 Laying Down Measures to Facilitate the Recognition of Medical Prescriptions Issued in Another Member State. Brussels, Belgium: European Union; 2012.
17. Sandoz Limited. Binocrit solution for injection in a pre-filled syringe. http://www.medicines.org.uk/emc/history/21625/SPC/BinocritþSolutionþforþInjectionþinþaþpre-filledþsyringe. Accessed November 27, 2014.
18. European Union. 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. Strasbourg, France: European Union; 2010.
19. Grampp G, Li E, Bonafede M, Felix T, Malecki M, Sprafka M. Traceability of Generic Enoxaparin in Active and Passive Surveillance Systems: Implications for Biosimilars Pharmacovigilance. Anaheim, CA: American Society of Health-System Pharmacists; 2014.
20. Cauchi R. State laws and legislation related to biologic medications and substitution of biosimilars. http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx. Published August 4, 2014. Accessed October 9, 2014.
21. Lietzan EF, Sim LE, Alexander EA. FDLI’s Food and Drug Policy Form—Biosimilar Naming: How do Adverse Event Reporting Data Support the Need for Distinct Nonproprietary Names for Biosimilars? Washington, DC: Food and Drug Law Institute; 2013.
22. Vermeer NS, Straus SM, Mantel-Teeuwisse AK, et al. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases. Drug Saf. 2013; 36(8):617-625.
23. Getz KA, Stergiopoulos S, Kaitin KI. Evaluating the completeness and accuracy of MedWatch data. Am J Ther. 2014;21(6): 442-446.
24. Calvo B, Zun˜iga L. EU’s new pharmacovigilance legislation: considerations for biosimilars. Drug Saf. 2014;37(1): 9-18.
25. Food and Drug Administration. Substance registration system: unique ingredient identifier (UNII). http://fdasis.nlm.nih.gov/srs/srs.jsp. Published October 2014. Access October 9, 2014.
26. American Diabetes Association. Insulin administration. Diabetes Care. 2003;26(suppl 1):4.
27. Grimberg A, Feudtner C, Gordon C. Consequences of brand switches during the course of pediatric growth hormone treatment. Endocr Pract. 2012;18(3):307-216.
28. Sandoz Limited. Zarzio SmPC update. http://www.medicines.org.uk/emc/history/22310/SPC/Zarzioþ30þMUþ0.5þmlþsolutionþforþinjectionþorþinfusionþinþpreþfilledþsyringe. Published 2011. Accessed November 27, 2013.
29. Vermeer NS, Spierings I, Mantel-Teeuwisse AK, et al. Traceability of biologicals: present challenges in pharmacovigilance. Expert Opin Drug Saf. 2015;14(1):63-72.