Comparative Effectiveness of Biosimilar, Reference Product and Other Erythropoiesis-Stimulating Agents (ESAs) Still Covered by Patent in Chronic Kidney Disease and Cancer Patients: An Italian Population-Based Study

PLoS ONE

Volumn 11, Issue 5, 2016, Pages

  Ingrasciotta, Ylenia ^a   Giorgianni, Francesco ^a   Marcianò, Ilaria ^a   Bolcato, Jenny ^b   Pirolo, Roberta ^b   Chinellato, Alessandro ^b   Ientile, Valentina ^a   Santoro, Domenico ^a   Genazzani, Armando A ^c   Alibrandi, Angela ^d   Fontana, Andrea ^e   Caputi, Achille P ^a,d   Trifirò, Gianluca ^a,d,f  

^a UNIVERSITY OF MESSINA   (Italy)

^b Public Health Department   (Italy)

^c UNIVERSITY OF EASTERN PIEDMONT   (Italy)

^d UNIVERSITY OF MESSINA   (Italy)

^e CASA SOLLIEVO DELLA SOFFERENZA HOSPITAL   (Italy)

^f ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANEMIC AGENT; BIOSIMILAR AGENT; CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; CYANOCOBALAMIN; HEMOGLOBIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; RETINOL; VITAMIN D; ANTINEOPLASTIC AGENT;

ADULT; AGE; AGED; ARTICLE; BLOOD TRANSFUSION; CHRONIC KIDNEY DISEASE; COHORT ANALYSIS; COMPARATIVE EFFECTIVENESS; DRUG EFFECT; DRUG RESPONSE; DRUG USE; END STAGE RENAL DISEASE; FEMALE; HEART FAILURE; HUMAN; HYPERTENSION; ITALY; MAJOR CLINICAL STUDY; MALE; NEOPLASM; OBSERVATIONAL STUDY; POPULATION RESEARCH; PREDICTOR VARIABLE; RETROSPECTIVE STUDY; SEX DIFFERENCE; TREATMENT DURATION; BLOOD; COMPARATIVE STUDY; METABOLISM; NEOPLASMS; PATENT; RENAL INSUFFICIENCY, CHRONIC; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BIOSIMILAR PHARMACEUTICALS; COHORT STUDIES; FEMALE; HEMATINICS; HEMOGLOBINS; HUMANS; ITALY; MALE; NEOPLASMS; PATENTS AS TOPIC; RENAL INSUFFICIENCY, CHRONIC; RETROSPECTIVE STUDIES;

EID: 84969271157     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0155805     Document Type: Article

References (28)

1. Aapro Matti S and Link Hartmut. September 2007 Update on EORTC Guidelines and Anemia Management with Erythropoiesis-Stimulating Agents. The Oncologist. 2008; 13:33-6. doi: 10.1634/ theoncologist.13-S3-33 PMID: 18458123
2. Determinazione AIFA. Aggiornamento del Piano terapeutico AIFA per prescrizione SSN di Eritropoietine (ex Nota 12). Available: http://www.agenziafarmaco.gov.it/sites/default/files/2010-07-29- determina-aggiornamento-template-nota-12-g.u.-75-del-31-03-2009.pdf.
3. Zuniga L, Calvo B. Biosimilars-the way forward. Hosp Pharm Europe. 2010; 50:33-4.
4. Mellstedt H. The future of biosimilars. Hosp Pharm Europe. 2010; 49: 33-34.
5. Genazzani AA, Biggio G, Caputi AP, Del Tacca M, Drago F, Fantozzi R, et al. Biosimilar drugs: concerns and opportunities. Biodrugs. 2007; 21:351-6. PMID: 18020619
6. European Medicines Agency. Committee for Medicinal Products 569 for Human Use (CHMP): guideline on similar biological 570 medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Available: http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2013/06/WC500144124.pdf.
7. Loiacono C, Sgroi C, Coppolino S, Cannata A, Ferrara R, Arcoraci V, et al. How much are biosimilars used in southern Italy? a retrospective analysis of epoetin utilization in the local health unit of Messina in the years 2010-2011. BioDrugs. 2012 Apr 1; 26(2):113-20. doi: 10.2165/11630770-000000000-00000 PMID: 22385406
8. Ingrasciotta Y, Giorgianni F, Bolcato J, Chinellato A, Pirolo R, Tari DU, et al. How Much Are Biosimilars Used in Clinical Practice? A Retrospective Italian Population-Based Study of Erythropoiesis-Stimulating Agents in the Years 2009-2013. BioDrugs. 2015 Jul 14.
9. Wizemann V, Rutkowski B, Baldamus C, Scigalla P, Koytchev R, Epoetin Zeta Study Group. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin. 2008; 24(3):625-37. doi: 10.1185/030079908X273264 PMID: 18208642
10. Krivoshiev S, Todorov VV, Manitius J, Czekalski S, Scigalla P, Koytchev R, et al. Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia. Curr Med Res Opin. 2008; 24(5):1407-15. doi: 10.1185/030079908X297402 PMID: 18394266
11. Krivoshiev S, Wizemann V, Czekalski S, Schiller A, Pljesa S, Wolf-Pflugmann M, et al. Therapeutic Equivalence of Epoetin Zeta and Alfa, Administered Subcutaneously, for Maintenance Treatment of Renal Anemia. Adv Ther (2010) 27(2):105-117. doi: 10.1007/s12325-010-0012-y PMID: 20369312
12. Haag-Weber M, Vetter A, Thyroff-Friesinger U. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol. 2009; 72(5):380-90. PMID: 19863881
13. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, et al. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2014; 12:CD010590. doi: 10.1002/14651858.CD010590.pub2 PMID: 25486075
14. Weigang-Köhler K, Vetter A, Thyroff-Friesinger U. HX575, recombinant human epoetin alfa, for the treatment of chemotherapy-associated symptomatic anaemia in patients with solid tumours. Onkologie. 2009 Apr; 32(4):168-74. doi: 10.1159/000200783 Epub 2009 Mar 6. PMID: 19372711
15. Michallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, et al. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014; 14:503. doi: 10.1186/1471-2407-14-503 PMID: 25011615
16. Bustos A, Álvarez R, Aramburo PM, Carabantes F, Díaz N, Florián J, et al. Evaluation of clinical use and effectiveness of darbepoetin alfa in cancer patients with chemotherapy-induced anemia. Curr Med Res Opin. 2012; 28(1):57-67. doi: 10.1185/03007995.2011.639352 PMID: 22070513
17. Kerkhofs L, Boschetti G, Lugini A, Stanculeanu DL, Palomo AG. Use of biosimilar epoetin to increase hemoglobin levels in patients with chemotherapy-induced anemia: real-life clinical experience. Future Oncol. 2012; 8(6):751-6. doi: 10.2217/fon.12.39 PMID: 22443466
18. Garzotto AR, Heine O, Turner M, Rebollo Laserna F, Lorenz A. Erythropoiesis-stimulating agents for the treatment of chemotherapy-induced anemia: comparisons from real-world clinical experience. Journal of Blood Medicine. 2014; 5: 43-48. doi: 10.2147/JBM.S57887 PMID: 24855398
19. Agenzia Italiana del Farmaco. Position Paper sui farmaci biosimilari. Available: http://www. agenziafarmaco.gov.it/it/content/position-paper. Accessed 2 Feb 2 2014.
20. Morkeberg J, Lundby C, Nissen-Lie G, Nielsen TK, Hemmersbach P, Damsgaard R. Detection of darbepoetin alfa misuse in urine and blood: preliminary investigation. Med Sci Sports Exerc. 2007; 39: 1742-7. PMID: 17909401
21. Ananth CV, Kleinbaum D G. Regression models for ordinal responses: A review of methods and applications. International Journal of Epidemiology. 1997; 26, 1323-1333. PMID: 9447413
22. Brant R. Assessing proportionality in the proportional odds model for ordinal logistic regression. Biometrics. 1990; 46, 1171-1178. PMID: 2085632
23. O'Connell A A. Logistic regression models for ordinal response variables. Thousand Oaks, CA: SAGE. 2006.
24. Agresti A. 2010. Analysis of Ordinal Categorical Data, Wiley, 2nd ed.
25. Liu I, and Agresti A. 2005. The analysis of ordered categorical data: An overview and a survey of recent developments (with discussion). Test 14: 1-73.
26. Ministero della Salute, Agenzia Italiana del Farmaco. Circolare AIFA del 3 agosto 2007. Linee guida per la classificazione e conduzione degli studi osservazionali sui farmaci. Available: http://xoomer. virgilio.it/pgiuff/osservazionali.pdf.
27. Haag-Weber M, Eckardt KU, Hörl WH, Roger SD, Vetter A, Roth K. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multicenter, randomized, double-blind study. Clin Nephrol. 2012 Jan; 77(1):8-17. PMID: 22185963
28. Minutolo R, Borzumati M, Sposini S, Abaterusso C, Carraro G, Santoboni A, et al. Dosing Penalty of Erythropoiesis-Stimulating Agents After Switching From Originator to Biosimilar Preparations in Stable Hemodialysis Patients. Am J Kidney Dis. 2016 Feb 13.