Risk management of biosimilars in oncology: Each medicine is a work in progress

Targeted Oncology

Volumn 7, Issue SUPPL.1, 2012, Pages

  Vulto, Arnold G ^a   Crow, Stacy A ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Biosimilar; Drug licensing; Drug safety; Monoclonal antibody; Oncology; Risk management

Indexed keywords

BIOSIMILAR AGENT; ERYTHROPOIETIN; GENERIC DRUG; GLYCERYL TRINITRATE; HEXAL; ISOTRETINOIN; MONOCLONAL ANTIBODY; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG;

BIOENGINEERING; COMPARATIVE STUDY; DRUG APPROVAL; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; EUROPEAN UNION; HUMAN; IMMUNOPATHOLOGY; MEDICAL DECISION MAKING; ONCOLOGY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; REVIEW; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SKIN NECROSIS;

BIOLOGICAL AGENTS; DRUG TOXICITY; HUMANS; RISK MANAGEMENT; THERAPEUTIC EQUIVALENCY; TISSUE DISTRIBUTION;

EID: 84857899040     PISSN: 17762596     EISSN: 1776260X     Source Type: Journal    
DOI: 10.1007/s11523-011-0188-3     Document Type: Review

References (27)

1. Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M (2004) Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 364:2021-2029 (Pubitemid 39593078)
2. Sayburn A (2010) Withdrawal of sibutramine leaves European doctors with just one obesity drug. BMJ 340:c477
3. Carpenter D, Ting MM (2005) Essay: the political logic of regulatory error. Nat Rev Drug Discov 4(10):819-823 (Pubitemid 41553962)
4. Miller HI, Henderson DR (2007) Governmental influences on drug development: striking a better balance. Nat Rev Drug Discov 6(7):532-539 (Pubitemid 47019442)
5. Goldman SA (1998) Limitations and strengths of spontaneous reports data. Clin Ther 20(Suppl C):C40-4
6. Vandenbroucke JP (2008) Observational research, randomised trials, and two views of medical science. PLoS Med 5(3):e67
7. CHMP (Committee for Medicinal Products for Human Use) (2005) Guideline on risk management systems for medicinal products for human use. European Medicines Agency document EMEA/CHMP/96268/ 2005 (accessible via www.ema.europa.eu)
8. Frau S, Font Pous M, Luppino MR et al (2010) Risk management plans: are they a tool for improving drug safety? Wur J Clin Pharmacol 66:785-790
9. Giezen TJ, Mantel-Teeuwisse AK, Straus SM et al (2009) Evaluation of post-authorization safety studies in the first cohort of EU risk management plans at time of regulatory approval. Drug Saf 32:1175-1187
10. Gascón P (2008) Safety update on erythropoiesis-stimulating agents: trials within and outside the accepted indications. Oncologist 13(Suppl 3):4-10, Review
11. Giezen TJ, Mantel-Teeuwisse AK, Straus SM et al (2008) Safety related regulatory actions for biologicals approved in the United States and the European Union. J Am Med Assoc 330:1887-1896
12. Mol PG, Straus SM, Piening S, de Vries JT, de Graeff PA, Haaijer-Ruskamp FM (2010) A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009. Drug Saf 33(6):463-474. doi:10.2165/11532840-000000000-00000
13. Kishimoto TK, Viswanathan K, Ganguly T, Elankumaran S, Smith S, Pelzer K et al (2010) Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med 362:1056
14. Zuniga L, Calve B (2010) Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf 19:661-669
15. Barbui C, Baschirotto C, Cipriani A (2011) EMA must improve the quality of its clinical trial reports. BMJ 25:342
16. Gøtzsche PC, Jørgensen AW (2011) Opening up data at the European Medicines Agency. BMJ 342:d2686
17. Thorpe RT, Waxhaw M (2006) Protein therapeutics and their immunogenicity. Eur J Hosp Pharmacy Practice 12(5):17-18
18. Bennet CL, Silver SM, Djulbegovic B et al (2008) Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer associated anemia. J A Med Assoc 299:914-924
19. Dicato M (2008) Venous thromboembolic events and erythropoiesis- stimulating agents: an update. Oncologist 13(Suppl 3):11-15
20. Dicato M, Lawny L (2009) Concerns about erythropoiesis stimulating agents in oncology: an update. Eur J Hosp Pharm Pract 15(1):25-27
21. Schrijvers D, Roila F (2009) Erythropoiesis stimulating agents in cancer patients: ESMO recommendations for use. Ann Onc 20 (Suppl 4):iv159-iv61
22. Stark CG (2009) Risk management of ESAs in cancer patients: a role for the hospital pharmacist. Eur J Hosp Pharm Pract 15 (4):54-58
23. Glaspy JA (2009) Erythropoietin in cancer patients. Annu Rev Med 60:181-192. doi:10.1136/bmj.d2686
24. Schneider C (2008) Monoclonal antibodies - Regulatory challenges. Cur Pharm Biotechnol 9:431-438
25. Schneider C, Kalinke (2008) Toward biosimilar monoclonal antibodies. Nat Biotechnol 26:985-990
26. CHMP (Committee for Medicinal Products for Human Use) (2010a) Draft guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. European Medicines Agency document EMEA/CHMP/BMWP/403543/2010 (version 18 November 2010, accessible via www.ema.europa.eu)
27. CHMP (Committee for Medicinal Products for Human Use) (2010b) Draft guideline on similar biological medicinal products containing monoclonal antibodies. European Medicines Agency document EMEA/CHMP/BMWP/86289/2010 (version 18 November 2010, accessible via www.ema.europa.eu)