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Volumn 38, Issue 6, 2018, Pages 481-490

Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; RECOMBINANT ERYTHROPOIETIN; EPO PROTEIN, HUMAN; ERYTHROPOIETIN;

EID: 85045139085     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.1007/s40261-018-0637-1     Document Type: Article
Times cited : (25)

References (59)
  • 1
    • 84894273048 scopus 로고    scopus 로고
    • Prevalence of anemia in chronic kidney disease in the United States
    • PID: 24392162
    • Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States. PLoS One. 2014;9:e84943.
    • (2014) PLoS One. , vol.9
    • Stauffer, M.E.1    Fan, T.2
  • 2
    • 25144514480 scopus 로고    scopus 로고
    • Anemia and cardiovascular disease, hospitalization, end stage renal disease, and death in older patients with chronic kidney disease
    • PID: 16142575
    • Li S, Foley RN, Collins AJ. Anemia and cardiovascular disease, hospitalization, end stage renal disease, and death in older patients with chronic kidney disease. Int Urol Nephrol. 2005;37:395–402.
    • (2005) Int Urol Nephrol. , vol.37 , pp. 395-402
    • Li, S.1    Foley, R.N.2    Collins, A.J.3
  • 3
    • 84979538941 scopus 로고    scopus 로고
    • Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia
    • PID: 27460779
    • Eriksson D, Goldsmith D, Teitsson S, Jackson J, van Nooten F. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrol. 2016;17:97.
    • (2016) BMC Nephrol. , vol.17 , pp. 97
    • Eriksson, D.1    Goldsmith, D.2    Teitsson, S.3    Jackson, J.4    van Nooten, F.5
  • 4
    • 77953343626 scopus 로고    scopus 로고
    • Burden of illness for patients with non-dialysis chronic kidney disease and anemia in the United States: review of the literature
    • PID: 20438399
    • van Nooten FE, Green J, Brown R, Finkelstein FO, Wish J. Burden of illness for patients with non-dialysis chronic kidney disease and anemia in the United States: review of the literature. J Med Econ. 2010;13:241–56.
    • (2010) J Med Econ. , vol.13 , pp. 241-256
    • van Nooten, F.E.1    Green, J.2    Brown, R.3    Finkelstein, F.O.4    Wish, J.5
  • 5
    • 85096646483 scopus 로고    scopus 로고
    • Chapter 3: Use of ESAs and other agents to treat anemia in CKD
    • KDIGO. Chapter 3: Use of ESAs and other agents to treat anemia in CKD. Kidney Int Suppl. 2012;2:299–310.
    • (2012) Kidney Int Suppl. , vol.2 , pp. 299-310
  • 6
    • 84923804295 scopus 로고    scopus 로고
    • The approval process for biosimilar erythropoiesis-stimulating agents
    • PID: 24970875
    • Wish JB. The approval process for biosimilar erythropoiesis-stimulating agents. Clin J Am Soc Nephrol. 2014;9:1645–51.
    • (2014) Clin J Am Soc Nephrol. , vol.9 , pp. 1645-1651
    • Wish, J.B.1
  • 9
    • 85029776942 scopus 로고    scopus 로고
    • European Medicines Agency. Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substanceAccessed 25 Jan 2018.
    • European Medicines Agency. Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf Accessed 25 Jan 2018.
    • Non-clinical and clinical issues. 2014
  • 11
    • 84857233319 scopus 로고    scopus 로고
    • The state of the art in the development of biosimilars
    • PID: 22318617
    • McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91:405–17.
    • (2012) Clin Pharmacol Ther. , vol.91 , pp. 405-417
    • McCamish, M.1    Woollett, G.2
  • 12
    • 84957933208 scopus 로고    scopus 로고
    • Totality of the evidence at work: the first US biosimilar
    • PID: 26634611
    • Holzmann J, Balser S, Windisch J. Totality of the evidence at work: the first US biosimilar. Expert Opin Biol Ther. 2016;16:137–42.
    • (2016) Expert Opin Biol Ther. , vol.16 , pp. 137-142
    • Holzmann, J.1    Balser, S.2    Windisch, J.3
  • 13
    • 85046954998 scopus 로고    scopus 로고
    • Biosimilarity guidelines
    • US Food and Drug Administration. Biosimilarity guidelines. November 2015. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm290967.htm. Accessed 14 June 2017.
    • (2015) November
    • Food, U.S.1    Administration, D.2
  • 14
    • 85019591876 scopus 로고    scopus 로고
    • A ‘global reference’ comparator for biosimilar development
    • PID: 28526943
    • Webster CJ, Woollett GR. A ‘global reference’ comparator for biosimilar development. BioDrugs. 2017;31:279–86.
    • (2017) BioDrugs. , vol.31 , pp. 279-286
    • Webster, C.J.1    Woollett, G.R.2
  • 17
    • 84871492817 scopus 로고    scopus 로고
    • Biosimilars: what clinicians should know
    • PID: 23093622
    • Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120:5111–7.
    • (2012) Blood. , vol.120 , pp. 5111-5117
    • Weise, M.1    Bielsky, M.C.2    De Smet, K.3
  • 18
    • 84873679430 scopus 로고    scopus 로고
    • Biosimilars in rheumatology: the wind of change
    • PID: 23390018
    • Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013;72:315–8.
    • (2013) Ann Rheum Dis. , vol.72 , pp. 315-318
    • Schneider, C.K.1
  • 19
    • 85046965129 scopus 로고    scopus 로고
    • European public assessment report variation
    • European Medicines Agency. European public assessment report variation, Aranesp-H-332-X-42. 2008. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000332/WC500026148.pdf. Accessed 14 June 2017.
    • (2008) Aranesp-H-332-X-42
  • 21
    • 84964555766 scopus 로고    scopus 로고
    • Quality and batch-to-batch consistency of original and biosimilar epoetin products
    • PID: 26869417
    • Halim LA, Brinks V, Jiskoot W, et al. Quality and batch-to-batch consistency of original and biosimilar epoetin products. J Pharm Sci. 2016;105:542–50.
    • (2016) J Pharm Sci. , vol.105 , pp. 542-550
    • Halim, L.A.1    Brinks, V.2    Jiskoot, W.3
  • 22
    • 74049092678 scopus 로고    scopus 로고
    • Clinical comparability and European biosimilar regulations
    • PID: 20062035
    • Schellekens H, Moors E. Clinical comparability and European biosimilar regulations. Nat Biotechnol. 2010;28:28–31.
    • (2010) Nat Biotechnol. , vol.28 , pp. 28-31
    • Schellekens, H.1    Moors, E.2
  • 23
    • 79952488808 scopus 로고    scopus 로고
    • Quality of original and biosimilar epoetin products
    • PID: 20886265
    • Brinks V, Hawe A, Basmeleh AH, et al. Quality of original and biosimilar epoetin products. Pharm Res. 2011;28:386–93.
    • (2011) Pharm Res. , vol.28 , pp. 386-393
    • Brinks, V.1    Hawe, A.2    Basmeleh, A.H.3
  • 24
    • 21444442363 scopus 로고    scopus 로고
    • Biosimilar epoetins: an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins
    • Combe C, Tredree RL, Schellekens H. Biosimilar epoetins: an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacother J Hum Pharmacol Drug Ther. 2005;25:954–62.
    • (2005) Pharmacother J Hum Pharmacol Drug Ther. , vol.25 , pp. 954-962
    • Combe, C.1    Tredree, R.L.2    Schellekens, H.3
  • 25
    • 84940439672 scopus 로고    scopus 로고
    • State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists
    • PID: 26223197
    • Covic A, Abraham I. State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists. Int Urol Nephrol. 2015;47:1529–39.
    • (2015) Int Urol Nephrol. , vol.47 , pp. 1529-1539
    • Covic, A.1    Abraham, I.2
  • 26
    • 84941425068 scopus 로고    scopus 로고
    • An integrated approach for a structural and functional evaluation of biosimilars: implications for erythropoietin
    • PID: 26334631
    • Gianoncelli A, Bonini SA, Bertuzzi M, et al. An integrated approach for a structural and functional evaluation of biosimilars: implications for erythropoietin. BioDrugs. 2015;29:285–300.
    • (2015) BioDrugs. , vol.29 , pp. 285-300
    • Gianoncelli, A.1    Bonini, S.A.2    Bertuzzi, M.3
  • 27
    • 67650067226 scopus 로고    scopus 로고
    • Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial
    • PID: 19463151
    • Sorgel F, Thyroff-Friesinger U, Vetter A, et al. Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial. BMC Clin Pharmacol. 2009;9:10.
    • (2009) BMC Clin Pharmacol , vol.9 , pp. 10
    • Sorgel, F.1    Thyroff-Friesinger, U.2    Vetter, A.3
  • 28
    • 79953154625 scopus 로고    scopus 로고
    • Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European-marketed epoetin alfas: a randomized prospective study
    • PID: 21410296
    • Lissy M, Ode M, Roth K. Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European-marketed epoetin alfas: a randomized prospective study. Drugs R D. 2011;11:61–75.
    • (2011) Drugs R D. , vol.11 , pp. 61-75
    • Lissy, M.1    Ode, M.2    Roth, K.3
  • 31
    • 84924404728 scopus 로고    scopus 로고
    • Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS)
    • PID: 25239637
    • Macdougall IC, Casadevall N, Locatelli F, et al. Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS). Nephrol Dial Transplant. 2015;30:451–60.
    • (2015) Nephrol Dial Transplant. , vol.30 , pp. 451-460
    • Macdougall, I.C.1    Casadevall, N.2    Locatelli, F.3
  • 32
    • 84855436897 scopus 로고    scopus 로고
    • Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study
    • PID: 22185963
    • 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 multi-center, randomized, double-blind study. Clin Nephrol. 2012;77:8–17.
    • (2012) Clin Nephrol. , vol.77 , pp. 8-17
    • Haag-Weber, M.1    Eckardt, K.U.2    Hörl, W.H.3    Roger, S.D.4    Vetter, A.5    Roth, K.6
  • 33
    • 84862644490 scopus 로고    scopus 로고
    • Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity
    • PID: 22094831
    • Seidl A, Hainzl O, Richter M, et al. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res. 2012;29:1454–67.
    • (2012) Pharm Res. , vol.29 , pp. 1454-1467
    • Seidl, A.1    Hainzl, O.2    Richter, M.3
  • 34
    • 85034005405 scopus 로고    scopus 로고
    • T-cell assays confirm immunogenicity of tungsten-induced erythropoietin aggregates associated with pure red cell aplasia
    • PID: 29296951
    • Rubic-Schneider T, Kuwana M, Christen B, et al. T-cell assays confirm immunogenicity of tungsten-induced erythropoietin aggregates associated with pure red cell aplasia. Blood Adv. 2017;1:367–79.
    • (2017) Blood Adv. , vol.1 , pp. 367-379
    • Rubic-Schneider, T.1    Kuwana, M.2    Christen, B.3
  • 35
    • 85028987211 scopus 로고    scopus 로고
    • Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients
    • PID: 28766493
    • Casadevall N, Dobronravov V, Eckardt KU, et al. Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients. Clin Nephrol. 2017;88:190–7.
    • (2017) Clin Nephrol. , vol.88 , pp. 190-197
    • Casadevall, N.1    Dobronravov, V.2    Eckardt, K.U.3
  • 36
    • 85046945836 scopus 로고    scopus 로고
    • Novartis. Press releaseAccessed 14 June 2017.
    • ® nephrology indication. 2016. https://www.novartis.com/news/media-releases/sandoz-receives-ec-approval-subcutaneous-route-administration-biosimilar. Accessed 14 June 2017.
    • ® nephrology indication. 2016
  • 37
    • 79958824101 scopus 로고    scopus 로고
    • Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies
    • PID: 21430643
    • Praditpornsilpa K, Tiranathanagul K, Kupatawintu P, et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int. 2011;80:88–92.
    • (2011) Kidney Int. , vol.80 , pp. 88-92
    • Praditpornsilpa, K.1    Tiranathanagul, K.2    Kupatawintu, P.3
  • 38
    • 84868666184 scopus 로고    scopus 로고
    • Biosimilar epoetins in nephrology—where are we now?
    • Goldsmith D, Gesualdo L. Biosimilar epoetins in nephrology—where are we now? Eur Nephrol. 2012;6:21–4.
    • (2012) Eur Nephrol. , vol.6 , pp. 21-24
    • Goldsmith, D.1    Gesualdo, L.2
  • 39
    • 85015588490 scopus 로고    scopus 로고
    • What do oncologists need to know about biosimilar products?
    • PID: 27733189
    • Leung LK, Mok K, Liu C, Chan SL. What do oncologists need to know about biosimilar products? Chin J Cancer. 2016;35:91.
    • (2016) Chin J Cancer. , vol.35 , pp. 91
    • Leung, L.K.1    Mok, K.2    Liu, C.3    Chan, S.L.4
  • 40
  • 41
    • 84957433088 scopus 로고    scopus 로고
    • Switching between epoetins: a practice in support of biosimilar use
    • PID: 26728875
    • D’Amore C, Da Cas R, Rossi M, Traversa G. Switching between epoetins: a practice in support of biosimilar use. BioDrugs. 2016;30:27–32.
    • (2016) BioDrugs. , vol.30 , pp. 27-32
    • D’Amore, C.1    Da Cas, R.2    Rossi, M.3    Traversa, G.4
  • 42
    • 85026840571 scopus 로고    scopus 로고
    • Effectiveness of switch to erythropoiesis-stimulating agent (ESA) biosimilars versus maintenance of ESA originators in the real-life setting: matched-control study in hemodialysis patients
    • PID: 28779268
    • Minutolo R, Bolasco P, Chiodini P, et al. Effectiveness of switch to erythropoiesis-stimulating agent (ESA) biosimilars versus maintenance of ESA originators in the real-life setting: matched-control study in hemodialysis patients. Clin Drug Investig. 2017;37:965–73.
    • (2017) Clin Drug Investig. , vol.37 , pp. 965-973
    • Minutolo, R.1    Bolasco, P.2    Chiodini, P.3
  • 43
    • 84876736657 scopus 로고    scopus 로고
    • A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia
    • PID: 23052412
    • Hörbrand F, Bramlage P, Fischaleck J, Hasford J, Brunkhorst R. A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia. Eur J Clin Pharmacol. 2013;69:929–36.
    • (2013) Eur J Clin Pharmacol. , vol.69 , pp. 929-936
    • Hörbrand, F.1    Bramlage, P.2    Fischaleck, J.3    Hasford, J.4    Brunkhorst, R.5
  • 44
    • 84864558128 scopus 로고    scopus 로고
    • Prospective multicenter study of HX575 (biosimilar epoetin-α) in patients with chronic kidney disease applying a target hemoglobin of 10–12 g/dl
    • PID: 22732334
    • Hörl WH, Locatelli F, Haag-Weber M, Ode M, Roth K, Epo-PASS Study Group. Prospective multicenter study of HX575 (biosimilar epoetin-α) in patients with chronic kidney disease applying a target hemoglobin of 10–12 g/dl. Clin Nephrol. 2012;78:24–32.
    • (2012) Clin Nephrol. , vol.78 , pp. 24-32
    • Hörl, W.H.1    Locatelli, F.2    Haag-Weber, M.3    Ode, M.4    Roth, K.5
  • 45
    • 44349139462 scopus 로고    scopus 로고
    • Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia
    • PID: 18394266
    • Krivoshiev S, Todorov VV, Manitius J, et al. Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia. Curr Med Res Opin. 2008;24:1407–15.
    • (2008) Curr Med Res Opin. , vol.24 , pp. 1407-1415
    • Krivoshiev, S.1    Todorov, V.V.2    Manitius, J.3
  • 46
    • 41149131276 scopus 로고    scopus 로고
    • Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment
    • PID: 18208642
    • 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;24:625–37.
    • (2008) Curr Med Res Opin. , vol.24 , pp. 625-637
    • Wizemann, V.1    Rutkowski, B.2    Baldamus, C.3    Scigalla, P.4    Koytchev, R.5
  • 47
    • 77952981609 scopus 로고    scopus 로고
    • Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia
    • PID: 20369312
    • Krivoshiev S, Wizemann V, Czekalski S, et al. Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia. Adv Ther. 2010;27:105–17.
    • (2010) Adv Ther. , vol.27 , pp. 105-117
    • Krivoshiev, S.1    Wizemann, V.2    Czekalski, S.3
  • 48
    • 70350776252 scopus 로고    scopus 로고
    • Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
    • PID: 19863881
    • Haag-Weber M, Vetter A, Thyroff-Friesinger U, INJ-Study Group. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol. 2009;72:380–90.
    • (2009) Clin Nephrol. , vol.72 , pp. 380-390
    • Haag-Weber, M.1    Vetter, A.2    Thyroff-Friesinger, U.3
  • 49
    • 85040521905 scopus 로고    scopus 로고
    • Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia: real-world effectiveness and safety in the MONITOR-CKD5 study
    • PID: 29168688
    • London G, Mann J, Goldsmith D, et al. Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia: real-world effectiveness and safety in the MONITOR-CKD5 study. Clin Nephrol. 2018;89:1–9.
    • (2018) Clin Nephrol. , vol.89 , pp. 1-9
    • London, G.1    Mann, J.2    Goldsmith, D.3
  • 50
    • 84948752185 scopus 로고    scopus 로고
    • Results from a safety cohort of patients with renal anemia receiving the biosimilar epoetinzeta: the PASCO I study
    • PID: 26396097
    • Dellanna F, Fluck RJ, Lonnemann G, Wild CA, Iwanowitsch A, Meissner R, Audhya P. Results from a safety cohort of patients with renal anemia receiving the biosimilar epoetinzeta: the PASCO I study. Clin Nephrol. 2015;84:280–8.
    • (2015) Clin Nephrol. , vol.84 , pp. 280-288
    • Dellanna, F.1    Fluck, R.J.2    Lonnemann, G.3    Wild, C.A.4    Iwanowitsch, A.5    Meissner, R.6    Audhya, P.7
  • 51
    • 84969271157 scopus 로고    scopus 로고
    • Comparative effectiveness of biosimilar, reference product and other Erythropoiesis-Stimulating Agents (ESAa) still covered by patent in chronic kidney disease and cancer patients: an italian population-based study
    • Ingrasciotta Y, Giorgianni F, Marciano I, et al. Comparative effectiveness of biosimilar, reference product and other Erythropoiesis-Stimulating Agents (ESAa) still covered by patent in chronic kidney disease and cancer patients: an italian population-based study. PLoS One. 2016;17(11):5.
    • (2016) PLoS One , vol.17 , Issue.11
    • Ingrasciotta, Y.1    Giorgianni, F.2    Marciano, I.3
  • 52
    • 85015227757 scopus 로고    scopus 로고
    • Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: a population-based cohort study in Italy. BMJ Open. 2017;7:e011637.53. GaBI Online
    • Trotta F, Belleudi V, Fusco D, et al. Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: a population-based cohort study in Italy. BMJ Open. 2017;7:e011637.53. GaBI Online. Biosimilars approved in Europe: June 2017 update. 2017. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed 14 June 2017.
    • (2017) Biosimilars approved in Europe: June 2017 update
    • Trotta, F.1    Belleudi, V.2    Fusco, D.3
  • 55
    • 84995494490 scopus 로고    scopus 로고
    • Introduction of biosimilar therapeutics into nephrology practice in the United States: report of a scientific workshop sponsored by the National Kidney Foundation
    • PID: 27599628
    • Wish JB, Charytan C, Chertow GM, et al. Introduction of biosimilar therapeutics into nephrology practice in the United States: report of a scientific workshop sponsored by the National Kidney Foundation. Am J Kidney Dis. 2016;68:843–52.
    • (2016) Am J Kidney Dis. , vol.68 , pp. 843-852
    • Wish, J.B.1    Charytan, C.2    Chertow, G.M.3
  • 56
    • 85046956273 scopus 로고    scopus 로고
    • Considerations in demonstrating interchangeability with a reference product
    • US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product. Guidance for industry: draft guidance. 2017. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Accessed 14 June 2017.
    • (2017) Guidance for industry: draft guidance
    • Food, U.S.1    Administration, D.2
  • 59
    • 85046936016 scopus 로고    scopus 로고
    • Briefing Document: BLA125545 “Epoetin Hospira
    • US Food and Drug Administration. Briefing Document: BLA125545 “Epoetin Hospira”, a proposed biosimilar to Epogen/Procrit (epoetin alfa). 2017. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM559967.pdf. Accessed 14 June 2017.
    • (2017) A proposed biosimilar to Epogen/Procrit (epoetin alfa)
    • Food, U.S.1    Administration, D.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.