Immunosuppression with Generics in Liver and Kidney Transplantation: A Real-World Evidence Study

References

• Marino ML, Rosa AC, Finocchietti M, et al. Temporal and spatial variability of immunosuppressive therapies in transplant patients: an observational study in Italy. Front Transplant. 2023;1:1060621. doi:10.3389/frtra.2022.1060621
   Google Scholar
• Tönshoff B. Immunosuppressive therapy post-transplantation in children: what the clinician needs to know. Expert Rev Clin Immunol. 2020;16(2):139–154. doi:10.1080/1744666X.2020.1714437
   PubMed Web of Science ®Google Scholar
• Van Gelder T. ESOT Advisory Committee on Generic Substitution. European Society for Organ Transplantation Advisory Committee recommendations on generic substitution of immunosuppressive drugs. Transpl Int. 2011;24(12):1135–1141. doi:10.1111/j.1432-2277.2011.01378.x
   PubMed Web of Science ®Google Scholar
• AIFA. Determinazione AIFA; 2016. Available from: http://www.agenziafarmaco.gov.it/sites/default/files/Determinazione_AIFA_n._5-2016.pdf. Accessed January 5, 2024.
   Google Scholar
• AIFA. Precisazioni AIFA su Tacrolimus; 2011. Available from: http://www.agenziafarmaco.gov.it/sites/default/files/precisazioni_aifa_su_tacrolimu.pdf. Accessed January 5, 2024.
   Google Scholar
• Molnar AO, Fergusson D, Tsampalieros AK, et al. Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis. BMJ. 2015;350:h3163.
   PubMedGoogle Scholar
• Rottembourg J. Generic Immunosuppression in Transplantation: a Controversial Analysis. J Med Toxicol Clin Forensic Med. 2019;5(1):1.
   Google Scholar
• Cattaneo D, Perico N, Remuzzi G, et al. Generic cyclosporine formulations: more open questions than answers. Transpl Int. 2005;18(4):371–378. doi:10.1111/j.1432-2277.2005.00078.x
   PubMed Web of Science ®Google Scholar
• Kahn J, Pregartner G, Schemmer P. Immunosuppression with generic tacrolimus in liver and kidney transplantation-systematic review and meta-analysis on biopsy-proven acute rejection and bioequivalence. Transpl Int. 2020;33(4):356–372. doi:10.1111/tri.13581
   PubMed Web of Science ®Google Scholar
• Son SY, Jang HR, Lee JE, et al. Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients. Drug Des Devel Ther. 2017;11:203–210. doi:10.2147/DDDT.S118154
   PubMed Web of Science ®Google Scholar
• Gantar K, Škerget K, Mochkin I, Bajc A. Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: bioequivalence Studies of Generic Once-Daily Tacrolimus. Drug Healthc Patient Saf. 2020;12:151–160. doi:10.2147/DHPS.S256455
   PubMed Web of Science ®Google Scholar
• Robertsen I, Åsberg A, Ingerø AO, et al. Use of generic tacrolimus in elderly renal transplant recipients: precaution is needed. Transplantation. 2015;99(3):528–532. doi:10.1097/TP.0000000000000384
   PubMed Web of Science ®Google Scholar
• SITO. Considerazioni sull’uso degli immunosoppressori equivalenti dopo trapianto d’organo solido; 2022. Available from: https://www.societaitalianatrapiantidiorgano.com/wpcontent/uploads/2015/04/ConsiderazioniSITO_farmaci_immunosoppressori_equivalenti.pdf. Accessed January 5, 2024.
   Google Scholar
• Belleudi V, Rosa AC, Finocchietti M, et al. An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: framework and perspectives of the CESIT project. Front Pharmacol. 2022;13:959267. doi:10.3389/fphar.2022.959267
   PubMed Web of Science ®Google Scholar
• Trifirò G, Gini R, Barone-Adesi F, et al. The role of European healthcare databases for post-marketing drug effectiveness, safety and value evaluation: where does Italy stand? Drug Saf. 2019;42(3):347–363. doi:10.1007/s40264-018-0732-5
   PubMed Web of Science ®Google Scholar
• Massari M, Spila Alegiani S, Da Cas R, et al. TheShinISS: un applicativo open-source per la conduzione di analisi distribuite in studi di farmacoepidemiologia di tipo multi-database. Boll Epidemiol Naz. 2020;1(2):39–45.
   Google Scholar
• Trifirò G, Isgrò V, Ingrasciotta Y, et al. Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: the VALORE Project. BioDrugs. 2021;35(6):749–764. doi:10.1007/s40259-021-00498-3
   PubMed Web of Science ®Google Scholar
• Spila Alegiani S, Morciano C, Menniti-Ippolito F, et al. Postmarketing observational study on the safety of 2021/2022 and 2022/2023 influenza vaccination campaigns in Italy: theShinISS-Vax|Flu study protocol. BMJ Open. 2023;13(8):e069858. doi:10.1136/bmjopen-2022-069858
   PubMedGoogle Scholar
• Italian Medicines Agency - AIFA. Monitoring of patent-expired non-biologic medicines. Available from: https://www.aifa.gov.it/en/monitoraggio-farmaci-non-biologici-A-brevetto-scaduto. Accessed January 5, 2024.
   Google Scholar
• Helmuth ME, Liu Q, Turenne MN, et al. Secular Trends in the Cost of Immunosuppressants after Solid Organ Transplantation in the United States. Clin J Am Soc Nephrol. 2019;14(3):421–430. doi:10.2215/CJN.10590918
   PubMed Web of Science ®Google Scholar
• The Medicines Utilisation Monitoring Centre. National Report on Medicines Use in Italy. Rome: Italian Medicines Agency; 2022.
   Google Scholar
• Harrison JJ, Schiff JR, Coursol CJ, et al. Generic immunosuppression in solid organ transplantation: a Canadian perspective. Transplantation. 2012;93(7):657–665. doi:10.1097/TP.0b013e3182445e9d
   PubMed Web of Science ®Google Scholar
• El Hajj S, Kim M, Phillips K, Gabardi S. Generic immunosuppression in transplantation: current evidence and controversial issues. Expert Rev Clin Immunol. 2015;11(5):659–672. doi:10.1586/1744666X.2015.1026895
   PubMed Web of Science ®Google Scholar
• Liu Q, Smith AR, Park JM, et al. The adoption of generic immunosuppressant medications in kidney, liver, and heart transplantation among recipients in Colorado or nationally with Medicare part D. Am J Transplant. 2018;18(7):1764–1773. doi:10.1111/ajt.14722
   PubMed Web of Science ®Google Scholar
• Lee RA, Gabardi S. Current trends in immunosuppressive therapies for renal transplant recipients. Am J Health Syst Pharm. 2012;69(22):1961–1975. doi:10.2146/ajhp110624
   PubMed Web of Science ®Google Scholar
• Taube D, Jones G, O’Beirne J, et al. Generic tacrolimus in solid organ transplantation. Clin Transplant. 2014;28(5):623–632. doi:10.1111/ctr.12336
   PubMed Web of Science ®Google Scholar
• Kahn D, Muller E, Pascoe M. Safe conversion to cicloral, a generic cylosporine, in both stable and de novo renal transplant recipients. Saudi J Kidney Dis Transpl. 2010;21(3):426–432.
   PubMedGoogle Scholar
• Diarra DA, Riegersperger M, Säemann MD, et al. Maintenance immunosuppressive therapy and generic cyclosporine A use in adult renal transplantation: a single center analysis. Kidney Int Suppl. 2010;115:S8–11. doi:10.1038/ki.2009.505
   Google Scholar
• Tarek BO, Nadia BF, Anis K, et al. Assessment of bioequivalence of a generic cyclosporine (Equoral) by a prospective randomized controlled trial on allogeneic stem cell transplant recipients. Transplant Proc. 2010;42(9):3735–3738. doi:10.1016/j.transproceed.2010.06.019
   PubMed Web of Science ®Google Scholar
• Niemczyk M, Paczek L. Generic formulation of cyclosporine A, Equoral®, in de novo kidney transplant recipients: five-year follow-up. Ann Transplant. 2011;16(2):59–62. doi:10.12659/AOT.881866
   PubMed Web of Science ®Google Scholar
• Durlik M, Paczek L, Rutkowski B, et al. The efficacy and safety of ciclosporin (Equoral®) capsules after renal transplantation: a multicentre, open-label, Phase IV clinical trial. Ann Transplant. 2010;15(3):51–59.
   PubMed Web of Science ®Google Scholar
• Spence MM, Nguyen LM, Hui RL, Chan J. Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system. Pharmacotherapy. 2012;32(11):981–987. doi:10.1002/phar.1130
   PubMed Web of Science ®Google Scholar
• Ensor CR, Trofe-Clark J, Gabardi S, et al. Generic maintenance immunosuppression in solid organ transplant recipients. Pharmacotherapy. 2011;31(11):1111–1129. doi:10.1592/phco.31.11.1111
   PubMed Web of Science ®Google Scholar
• McDevitt-Potter LM, Sadaka B, Tichy EM, Rogers CC, Gabardi S. A multicenter experience with generic tacrolimus conversion. Transplantation. 2011;92(6):653–657. doi:10.1097/TP.0b013e31822a79ad
   PubMed Web of Science ®Google Scholar
• Momper JD, Ridenour TA, Schonder KS, et al. The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function. Am J Transplant. 2011;11(9):1861. doi:10.1111/j.1600-6143.2011.03615.x
   PubMed Web of Science ®Google Scholar
• Kim JM, Kwon CH, Yun IJ, et al. A multicenter experience with generic mycophenolate mofetil conversion in stable liver transplant recipients. Ann Surg Treat Res. 2014;86(4):192–198. doi:10.4174/astr.2014.86.4.192
   PubMed Web of Science ®Google Scholar