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Volumn 18, Issue 7, 2010, Pages 489-498

Clinical concerns of immunogenicity produced at cellular levels by biopharmaceuticals following their parenteral administration into human body

Author keywords

Biopharmaceuticals; Biosimilars; Clinical concerns; Immune response; Therapy

Indexed keywords

ABSEAMED; ALPHA INTERFERON; ALPHA2B INTERFERON; ALPHEON; BIOGRASTIM; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; DRUG ANTIBODY; EPOKINE; EPORON; ESPOGEN; HEXAL; HUMAN GROWTH HORMONE; HYLENEX; NEUTRALIZING ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PEGETRON; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; PROTHROMBIN COMPLEX; RATIOGRASTIM; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GLUCAGON; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT GROWTH HORMONE; REIFERON RETARD; RELIFERON; RIBAVIRIN; SALCATONIN; SB 309; TEVAGRASTIM; UNCLASSIFIED DRUG; WEPOX; BIOLOGICAL PRODUCT;

EID: 77954269066     PISSN: 1061186X     EISSN: 10292330     Source Type: Journal    
DOI: 10.3109/10611861003649746     Document Type: Review
Times cited : (38)

References (96)
  • 1
    • 0023071853 scopus 로고
    • Clinical trial with authentic recom-binant somatropin in Sweden and Finland
    • Albertsson-Wikland K. (1987). Clinical trial with authentic recom-binant somatropin in Sweden and Finland. Acta Paediatr Scand Suppl, 331, 28-34.
    • (1987) Acta Paediatr Scand Suppl , vol.331 , pp. 28-34
    • Albertsson-Wikland, K.1
  • 2
    • 0042420751 scopus 로고    scopus 로고
    • Pure red-cell aplasia: An emerging epidemic in dialysis patients?
    • Anand S, Nissenson AR. (2003). Pure red-cell aplasia: an emerging epidemic in dialysis patients? Perit Dial Int, 23, 317-319.
    • (2003) Perit Dial Int , vol.23 , pp. 317-319
    • Anand, S.1    Nissenson, A.R.2
  • 3
    • 85069251749 scopus 로고    scopus 로고
    • Australian Drug Evaluation Committee. [cited August 3, 2007]. last accessed January 2010
    • Australian Drug Evaluation Committee.(2005). 240th Meeting Recommendations. [cited August 3, 2007]. http://www.tga. gov.au/docs/html/adec/ adec0240.htm, (last accessed January 2010).
    • (2005) 240th Meeting Recommendations
  • 4
    • 27744500483 scopus 로고    scopus 로고
    • Long-term outcome of individuals with pure red cell aplasia and antierythro-poietin antibodies in patients treated with recombinant epoetin: A follow-up report from the Research on Adverse Drug Events and Reports (RADAR) Project
    • Bennett CL, Cournoyer D, Carson KR, et al. (2005). Long-term outcome of individuals with pure red cell aplasia and antierythro-poietin antibodies in patients treated with recombinant epoetin: a follow-up report from the Research on Adverse Drug Events and Reports (RADAR) Project. Blood, 106, 3343-3347.
    • (2005) Blood , vol.106 , pp. 3343-3347
    • Bennett, C.L.1    Cournoyer, D.2    Carson, K.R.3
  • 5
    • 4644351840 scopus 로고    scopus 로고
    • Pure red-cell aplasia and epoetin therapy
    • Bennett CL, Luminari S, Nissenson AR, et al. (2004). Pure red-cell aplasia and epoetin therapy. N Engl J Med, 351, 1403-1408.
    • (2004) N Engl J Med , vol.351 , pp. 1403-1408
    • Bennett, C.L.1    Luminari, S.2    Nissenson, A.R.3
  • 6
    • 0025098971 scopus 로고
    • Incidence of response and long-term follow-up in patients with hairy cell leukemia treated with recombinant interferon alfa-2a
    • Berman E, Heller G, Kempin S, Gee T, Tran LL, Clarkson B. (1990). Incidence of response and long-term follow-up in patients with hairy cell leukemia treated with recombinant interferon alfa-2a. Blood, 75, 839-845. (Pubitemid 20067180)
    • (1990) Blood , vol.75 , Issue.4 , pp. 839-845
    • Berman, E.1    Heller, G.2    Kempin, S.3    Gee, T.4    Tran, L.-L.5    Clarkson, B.6
  • 7
    • 33846339172 scopus 로고    scopus 로고
    • EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update
    • Bokemeyer C, Aapro MS, Courdi A, et al. (2007). EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer, 43, 258-270.
    • (2007) Eur J Cancer , vol.43 , pp. 258-270
    • Bokemeyer, C.1    Aapro, M.S.2    Courdi, A.3
  • 8
    • 0028219410 scopus 로고
    • Interferon antibodies in patients with chronic hepatitic C virus infection treated with recombinant interferon alpha-2 alpha
    • Bonetti P, Diodati G, Drago C, et al. (1994). Interferon antibodies in patients with chronic hepatitic C virus infection treated with recombinant interferon alpha-2 alpha. J Hepatol, 20, 416-420.
    • (1994) J Hepatol , vol.20 , pp. 416-420
    • Bonetti, P.1    Diodati, G.2    Drago, C.3
  • 9
    • 19044397056 scopus 로고    scopus 로고
    • Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: Solving the mystery
    • Boven K, Knight J, Bader F, Rossert J, Eckardt KU, Casadevall N. (2005a). Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mystery. Nephrol Dial Transplant, 20(Suppl 3), iii33-iii40.
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 3
    • Boven, K.1    Knight, J.2    Bader, F.3    Rossert, J.4    Eckardt, K.U.5    Casadevall, N.6
  • 10
    • 19044392727 scopus 로고    scopus 로고
    • Te increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes
    • Boven K, Stryker S, Knight J, et al. (2005b). Te increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int, 67, 2346-2353.
    • (2005) Kidney Int , vol.67 , pp. 2346-2353
    • Boven, K.1    Stryker, S.2    Knight, J.3
  • 11
    • 0030856842 scopus 로고    scopus 로고
    • Protein aggregates seem to play a key role among the parameters infuencing the anti-genicity of interferon alpha (IFN-alpha) in normal and transgenic mice
    • Braun A, Kwee L, Labow MA, Alsenz J. (1997). Protein aggregates seem to play a key role among the parameters infuencing the anti-genicity of interferon alpha (IFN-alpha) in normal and transgenic mice. Pharm Res, 14, 1472-1478.
    • (1997) Pharm Res , vol.14 , pp. 1472-1478
    • Braun, A.1    Kwee, L.2    Labow, M.A.3    Alsenz, J.4
  • 12
    • 0028266130 scopus 로고
    • A multicenter study of recombinant factor VIII (recombinate): Safety, efcacy, and inhibitor risk in previously untreated patients with hemophilia A
    • Te Recombinate Study Group
    • Bray GL, Gomperts ED, Courter S, et al. (1994). A multicenter study of recombinant factor VIII (recombinate): safety, efcacy, and inhibitor risk in previously untreated patients with hemophilia A. Te Recombinate Study Group. Blood, 83, 2428-2435.
    • (1994) Blood , vol.83 , pp. 2428-2435
    • Bray, G.L.1    Gomperts, E.D.2    Courter, S.3
  • 13
    • 77954277320 scopus 로고    scopus 로고
    • In vitro toxicokinetics and dynamics: Modeling and interpretation of toxicity data
    • Gad SC. (ed.) NJ: John Wiley & Sons, Inc. Chap. 15
    • Bruinink A. (2008). In vitro toxicokinetics and dynamics: modeling and interpretation of toxicity data. In Gad SC. (ed.), Preclinical Development Handbook: Toxicology. NJ: John Wiley & Sons, Inc., Chap. 15, pp. 509-550.
    • (2008) Preclinical Development Handbook: Toxicology , pp. 509-550
    • Bruinink, A.1
  • 14
    • 0036319285 scopus 로고    scopus 로고
    • Antibodies against rHuEPO: Native and recom-binant
    • Casadevall N. (2002). Antibodies against rHuEPO: native and recom-binant. Nephrol Dial Transplant, 17(Suppl 5), 42-47.
    • (2002) Nephrol Dial Transplant , vol.17 , Issue.SUPPL. 5 , pp. 42-47
    • Casadevall, N.1
  • 16
    • 21444442363 scopus 로고    scopus 로고
    • Biosimilar epoetins: An analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharma-ceutical proteins
    • Combe C, Tredree RL, Schellekens H. (2005). Biosimilar epoetins: an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharma-ceutical proteins. Pharmacotherapy, 25, 954-962.
    • (2005) Pharmacotherapy , vol.25 , pp. 954-962
    • Combe, C.1    Tredree, R.L.2    Schellekens, H.3
  • 17
    • 14044259130 scopus 로고    scopus 로고
    • Anti-erythropoietin antibody-mediated pure red cell aplasia after treatment with recombinant erythropoietin products: Recommendations for minimization of risk
    • Cournoyer D, Tofelmire EB, Wells GA, et al. (2004). Anti-erythropoietin antibody-mediated pure red cell aplasia after treatment with recombinant erythropoietin products: recommendations for minimization of risk. J Am Soc Nephrol, 15, 2728-2734.
    • (2004) J Am Soc Nephrol , vol.15 , pp. 2728-2734
    • Cournoyer, D.1    Tofelmire, E.B.2    Wells, G.A.3
  • 18
    • 34248176896 scopus 로고    scopus 로고
    • Biosimilars: Recent developments
    • Covic A, Kuhlmann MK. (2007). Biosimilars: recent developments. Int Urol Nephrol, 39, 261-266.
    • (2007) Int Urol Nephrol , vol.39 , pp. 261-266
    • Covic, A.1    Kuhlmann, M.K.2
  • 19
    • 33748921915 scopus 로고    scopus 로고
    • Biophysical comparability of the same protein from diferent manufacturers: A case study using Epoetin alfa from Epogen and Eprex
    • Deechongkit S, Aoki KH, Park SS, Kerwin BA. (2006). Biophysical comparability of the same protein from diferent manufacturers: a case study using Epoetin alfa from Epogen and Eprex. J Pharm Sci, 95, 1931-1943.
    • (2006) J Pharm Sci , vol.95 , pp. 1931-1943
    • Deechongkit, S.1    Aoki, K.H.2    Park, S.S.3    Kerwin, B.A.4
  • 20
    • 34249042875 scopus 로고    scopus 로고
    • Prediction of immunogenicity for therapeutic proteins: State of the art
    • De Groot AS, Moise L. (2007). Prediction of immunogenicity for therapeutic proteins: state of the art. Curr Opin Drug Discov Dev, 10, 332-340.
    • (2007) Curr Opin Drug Discov Dev , vol.10 , pp. 332-340
    • De Groot, A.S.1    Moise, L.2
  • 21
    • 63749128279 scopus 로고    scopus 로고
    • Reducing risk, improving outcomes: Bioengineering less immunogenic protein therapeutics
    • De Groot AS, Martin W. (2009). Reducing risk, improving outcomes: bioengineering less immunogenic protein therapeutics. Clin Immunol, 131, 189-201.
    • (2009) Clin Immunol , vol.131 , pp. 189-201
    • De Groot, A.S.1    Martin, W.2
  • 22
    • 36049006592 scopus 로고    scopus 로고
    • Immunogenicity of protein therapeutics
    • De Groot AS, Scott DW. (2007). Immunogenicity of protein therapeutics. Trends Immunol, 28, 482-490.
    • (2007) Trends Immunol , vol.28 , pp. 482-490
    • De Groot, A.S.1    Scott, D.W.2
  • 23
    • 54049088585 scopus 로고    scopus 로고
    • Activation of natural regulatory T cells by IgG Fc-derived peptide "tregitopes"
    • De Groot AS, Moise L, McMurry JA, et al. (2008). Activation of natural regulatory T cells by IgG Fc-derived peptide "Tregitopes". Blood, 112, 3303-3311.
    • (2008) Blood , vol.112 , pp. 3303-3311
    • De Groot, A.S.1    Moise, L.2    McMurry, J.A.3
  • 24
    • 0024730839 scopus 로고
    • Low incidence of neutralizing antibody formation to interferon-alpha 2b in human recipients
    • Dianzani F, Antonelli G, Amicucci P, Cefaro A, Pintus C. (1989). Low incidence of neutralizing antibody formation to interferon-alpha 2b in human recipients. J Interferon Res, 9(Suppl 1), S33-S36.
    • (1989) J Interferon Res , vol.9 , Issue.SUPPL. 1
    • Dianzani, F.1    Antonelli, G.2    Amicucci, P.3    Cefaro, A.4    Pintus, C.5
  • 25
    • 0027481146 scopus 로고
    • Randomized controlled trial of recombinant alpha-2a-interferon for chronic hepatitis C. Comparison of alanine aminotransferase normalization versus loss of HCV RNA and anti-HCV IgM
    • Douglas DD, Rakela J, Lin HJ, et al. (1993). Randomized controlled trial of recombinant alpha-2a-interferon for chronic hepatitis C. Comparison of alanine aminotransferase normalization versus loss of HCV RNA and anti-HCV IgM. Dig Dis Sci, 38, 601-607.
    • (1993) Dig Dis Sci , vol.38 , pp. 601-607
    • Douglas, D.D.1    Rakela, J.2    Lin, H.J.3
  • 26
    • 39549105384 scopus 로고    scopus 로고
    • Scientifc and legal viability of follow-on protein drugs
    • Dudzinski DM, Kesselheim AS. (2008). Scientifc and legal viability of follow-on protein drugs. N Engl J Med, 358, 843-849.
    • (2008) N Engl J Med , vol.358 , pp. 843-849
    • Dudzinski, D.M.1    Kesselheim, A.S.2
  • 27
    • 0038752054 scopus 로고    scopus 로고
    • Pure red-cell aplasia due to anti-erythropoietin antibodies
    • Eckardt KU, Casadevall N. (2003). Pure red-cell aplasia due to anti-erythropoietin antibodies. Nephrol Dial Transplant, 18, 865-869.
    • (2003) Nephrol Dial Transplant , vol.18 , pp. 865-869
    • Eckardt, K.U.1    Casadevall, N.2
  • 28
    • 0026548917 scopus 로고
    • Incidence of development of factor VIII and factor IX inhibitors in haemophiliacs
    • Ehrenforth S, Kreuz W, Scharrer I, et al. (1992). Incidence of development of factor VIII and factor IX inhibitors in haemophiliacs. Lancet, 339, 594-598.
    • (1992) Lancet , vol.339 , pp. 594-598
    • Ehrenforth, S.1    Kreuz, W.2    Scharrer, I.3
  • 29
    • 84875904527 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed on March 4, 2009
    • European Medicines Agency. (2006). Omnitrope: scientifc discussion. http://www.emea.europa.eu/humandocs/PDFs/EPAR/Omnitrope/060706en6.pdf (Last accessed on March 4, 2009).
    • (2006) Omnitrope: Scientifc Discussion.
  • 30
    • 85020908558 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2006a). Valtropin: EPAR summary for the public. http://www.emea.europa.eu/humandocs/PDFs/EPAR/valtropin/H-602-en1.pdf (Last accessed March 4, 2009).
    • (2006) Valtropin: EPAR Summary for the Public.
  • 31
    • 85069248055 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2006b). Valtropin: scientifc discussion. http://www.emea.europa.eu/humandocs/PDFs/EPAR/valtropin/H-602-en6.pdf (Last accessed March 4, 2009).
    • (2006) Valtropin: Scientifc Discussion.
  • 32
    • 67349273783 scopus 로고    scopus 로고
    • Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2006). Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant erythropoietins. http://www.emea. europa.eu/pdfs/human/biosimilar/9452605en.pdf (Last accessed March 4, 2009).
    • (2006) Guidance on Similar Medicinal Products Containing Recombinant Erythropoietins.
  • 33
    • 77954299191 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 3, 2009
    • European Medicines Agency. (2007). Omnitrope: EPAR summary for the public. http://www.emea.europa.eu/humandocs/PDFs/EPAR/Omnitrope/060706en1.pdf (Last accessed March 3, 2009).
    • (2007) Omnitrope: EPAR Summary for the Public.
  • 34
    • 85038128701 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2007). Epoetin alfa HEXAL: scientifc discussion. http://www.emea.europa.eu/humandocs/PDFs/EPAR/epoetinalfahexal/H- 726-en6.pdf (Last accessed March 4, 2009).
    • (2007) Epoetin Alfa HEXAL: Scientifc Discussion
  • 35
    • 85038127732 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2007). Binocrit: scientifc discussion. http://www.emea.europa.eu/humandocs/PDFs/EPAR/binocrit/H-725-en6.pdf (Last accessed March 4, 2009).
    • (2007) Binocrit: Scientifc Discussion.
  • 36
    • 85038127732 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2007). Abseamed: scientifc discussion. http://www.emea.europa.eu/humandocs/PDFs/EPAR/abseamed/H-727-en6.pdf (Last accessed March 4, 2009).
    • (2007) Abseamed: Scientifc Discussion.
  • 37
    • 77954299191 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2007). Silapo: EPAR summary for the public. http://www.emea.europa.eu/humandocs/PDFs/EPAR/silapo/H-760-en1.pdf (Last accessed March 4, 2009).
    • (2007) Silapo: EPAR Summary for the Public.
  • 38
    • 77949550988 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2007). Silapo: scientifc discussion. http://www.emea.europa.eu/humandocs/PDFs/EPAR/silapo/H-760-en6.pdf (Last accessed March 4, 2009).
    • (2007) Silapo: Scientifc Discussion.
  • 39
    • 67349180719 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2007). Retacrit: scientifc discussion. http://www.emea.europa.eu/humandocs/PDFs/EPAR/retacrit/H-872-en6.pdf (Last accessed March 4, 2009).
    • (2007) Retacrit: Scientifc Discussion.
  • 40
    • 77954270377 scopus 로고    scopus 로고
    • European Medicines Agency. Last accessed March 4, 2009
    • European Medicines Agency. (2008). Retacrit: EPAR summary for the public. http://www.emea.europa.eu/humandocs/PDFs/EPAR/retacrit/H-872-en1.pdf (Last accessed March 4, 2009).
    • (2008) Retacrit: EPAR Summary for the Public.
  • 41
    • 0024042339 scopus 로고
    • Anti-interferon antibodies: A perspective
    • Figlin RA, Itri LM. (1988). Anti-interferon antibodies: a perspective. Semin Hematol, 25, 9-15.
    • (1988) Semin Hematol , vol.25 , pp. 9-15
    • Figlin, R.A.1    Itri, L.M.2
  • 42
    • 0024402892 scopus 로고
    • Recombinant human interferon (IFN) alpha-2b in chronic myelogenous leukaemia: Dose dependency of response and frequency of neutralizing anti-interferon antibodies
    • Freund M, von Wussow P, Diedrich H, et al. (1989). Recombinant human interferon (IFN) alpha-2b in chronic myelogenous leukaemia: dose dependency of response and frequency of neutralizing anti-interferon antibodies. Br J Haematol, 72, 350-356.
    • (1989) Br J Haematol , vol.72 , pp. 350-356
    • Freund, M.1    Von Wussow, P.2    Diedrich, H.3
  • 43
    • 17644386205 scopus 로고    scopus 로고
    • Antibody-mediated side efects of recombinant proteins
    • Frost H. (2005). Antibody-mediated side efects of recombinant proteins. Toxicology, 209, 155-160.
    • (2005) Toxicology , vol.209 , pp. 155-160
    • Frost, H.1
  • 44
    • 47349126691 scopus 로고    scopus 로고
    • Biosimilars: Policy, clinical, and regulatory considerations
    • Gottlieb S. (2008). Biosimilars: policy, clinical, and regulatory considerations. Am J Health Syst Pharm, 65, S2-S8.
    • (2008) Am J Health Syst Pharm , vol.65
    • Gottlieb, S.1
  • 45
    • 0027528498 scopus 로고
    • Factor VIII inhibitors: A continuing problem
    • Hoyer LW. (1993). Factor VIII inhibitors: a continuing problem. J Lab Clin Med, 121, 385-387.
    • (1993) J Lab Clin Med , vol.121 , pp. 385-387
    • Hoyer, L.W.1
  • 46
    • 0029361549 scopus 로고
    • Factor VIII inhibitors
    • Hoyer LW. (1995). Factor VIII inhibitors. Curr Opin Hematol, 2, 365-371.
    • (1995) Curr Opin Hematol , vol.2 , pp. 365-371
    • Hoyer, L.W.1
  • 47
    • 0037082566 scopus 로고    scopus 로고
    • Potential cost savings of erythropoietin administration in end-stage renal disease
    • Hynes DM, Stroupe KT, Greer JW, et al. (2002). Potential cost savings of erythropoietin administration in end-stage renal disease. Am J Med, 112, 169-175.
    • (2002) Am J Med , vol.112 , pp. 169-175
    • Hynes, D.M.1    Stroupe, K.T.2    Greer, J.W.3
  • 48
    • 85069251837 scopus 로고    scopus 로고
    • Important Drug Safety Update EPREX. Health Canada. [cited August 22, 2007]. Last accessed December 4, 2009
    • Important Drug Safety Update EPREX. (2002). (Epoetin alfa)-pure red cell aplasia (PRCA, Erythroblastopenia). Health Canada. [cited August 22, 2007]. http://www.hc-sc.gc.ca/dhp-mps/alt-for-mats/hpfbdgpsa/pdf/medef/ eprex-2-hpc-cps-e.pdf. 2007 (Last accessed December 4, 2009).
    • (2002) Epoetin Alfa)-pure Red Cell Aplasia (PRCA, Erythroblastopenia)
  • 49
    • 0022457407 scopus 로고
    • Safety and tolerance of recombinant interferon alfa-2a (Roferon-A) in cancer patients
    • Jones GJ, Itri LM. (1986). Safety and tolerance of recombinant interferon alfa-2a (Roferon-A) in cancer patients. Cancer, 57, 1709-1715.
    • (1986) Cancer , vol.57 , pp. 1709-1715
    • Jones, G.J.1    Itri, L.M.2
  • 50
    • 0022590488 scopus 로고
    • Clinical studies with recombinant-DNA-derived methionyl human growth hormone in growth hormone defcient children
    • Kaplan SL, Underwood LE, August GP, et al. (1986). Clinical studies with recombinant-DNA-derived methionyl human growth hormone in growth hormone defcient children. Lancet, 1, 697-700.
    • (1986) Lancet , vol.1 , pp. 697-700
    • Kaplan, S.L.1    Underwood, L.E.2    August, G.P.3
  • 51
    • 0032253569 scopus 로고    scopus 로고
    • Subcutaneous erythropoietin therapy: Efcacy and economic implications
    • Kaufman JS. (1998). Subcutaneous erythropoietin therapy: efcacy and economic implications. Am J Kidney Dis, 32, S147-S151.
    • (1998) Am J Kidney Dis , vol.32
    • Kaufman, J.S.1
  • 52
    • 57049111999 scopus 로고    scopus 로고
    • Pure red cell aplasia due to follow-on epoetin
    • Keithi-Reddy SR, Kandasamy S, Singh AK. (2008). Pure red cell aplasia due to follow-on epoetin. Kidney Int, 74, 1617-1622.
    • (2008) Kidney Int , vol.74 , pp. 1617-1622
    • Keithi-Reddy, S.R.1    Kandasamy, S.2    Singh, A.K.3
  • 53
    • 48949117123 scopus 로고    scopus 로고
    • Pharmacy and pharmacology of biosimilars
    • Krämer I. (2008). Pharmacy and pharmacology of biosimilars. J Endocrinol Invest, 31, 479-488.
    • (2008) J Endocrinol Invest , vol.31 , pp. 479-488
    • Krämer, I.1
  • 54
    • 67449138587 scopus 로고    scopus 로고
    • Biosimilars-science, status, and strategic perspective
    • Kresse GB. (2009). Biosimilars-science, status, and strategic perspective. Eur J Pharm Biopharm, 72, 479-486.
    • (2009) Eur J Pharm Biopharm , vol.72 , pp. 479-486
    • Kresse, G.B.1
  • 55
    • 23744481594 scopus 로고    scopus 로고
    • Antibodies against erythropoi-etin and other protein-based therapeutics: An overview
    • Kromminga A, Schellekens H. (2005). Antibodies against erythropoi-etin and other protein-based therapeutics: an overview. Ann N Y Acad Sci, 1050, 257-265.
    • (2005) Ann N y Acad Sci , vol.1050 , pp. 257-265
    • Kromminga, A.1    Schellekens, H.2
  • 57
    • 4344581912 scopus 로고    scopus 로고
    • Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure
    • Locatelli F, Aljama P, Bárány P, et al. (2004). Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 19(Suppl 2), ii1-ii47.
    • (2004) Nephrol Dial Transplant , vol.19 , Issue.SUPPL. 2
    • Locatelli, F.1    Aljama, P.2    Bárány, P.3
  • 58
    • 0025607230 scopus 로고
    • Interferon antibodies may negate the antiviral efects of recombinant alpha-interferon treatment in patients with chronic hepatitis B virus infection
    • Lok AS, Lai CL, Leung EK. (1990). Interferon antibodies may negate the antiviral efects of recombinant alpha-interferon treatment in patients with chronic hepatitis B virus infection. Hepatology, 12, 1266-1270.
    • (1990) Hepatology , vol.12 , pp. 1266-1270
    • Lok, A.S.1    Lai, C.L.2    Leung, E.K.3
  • 59
    • 0025933542 scopus 로고
    • Development of anti-hGH antibodies during therapy with authentic human growth hormone
    • Lundin K, Berger L, Blomberg F, Wilton P. (1991). Development of anti-hGH antibodies during therapy with authentic human growth hormone. Acta Paediatr Scand Suppl, 372, 167-168.
    • (1991) Acta Paediatr Scand Suppl , vol.372 , pp. 167-168
    • Lundin, K.1    Berger, L.2    Blomberg, F.3    Wilton, P.4
  • 60
    • 0033935277 scopus 로고    scopus 로고
    • Inhibitor antibodies to factor VIII and factor IX: Management
    • Lusher JM. (2000). Inhibitor antibodies to factor VIII and factor IX: management. Semin Tromb Hemost, 26, 179-188.
    • (2000) Semin Tromb Hemost , vol.26 , pp. 179-188
    • Lusher, J.M.1
  • 61
    • 0027473752 scopus 로고
    • Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A. Safety, efcacy, and development of inhibitors
    • Kogenate Previously Untreated Patient Study Group
    • Lusher JM, Arkin S, Abildgaard C F, Schwartz RS. (1993). Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A. Safety, efcacy, and development of inhibitors. Kogenate Previously Untreated Patient Study Group. N Engl J Med, 328, 453-459.
    • (1993) N Engl J Med , vol.328 , pp. 453-459
    • Lusher, J.M.1    Arkin, S.2    Abildgaard, C.F.3    Schwartz, R.S.4
  • 62
    • 0027397680 scopus 로고
    • Five-year follow-up of growth hormone antibodies in growth hormone defcient children treated with recombinant human growth hormone
    • Massa G, Vanderschueren-Lodeweyckx M, Bouillon R. (1993). Five-year follow-up of growth hormone antibodies in growth hormone defcient children treated with recombinant human growth hormone. Clin Endocrinol (Oxf), 38, 137-142.
    • (1993) Clin Endocrinol (Oxf) , vol.38 , pp. 137-142
    • Massa, G.1    Vanderschueren-Lodeweyckx, M.2    Bouillon, R.3
  • 63
    • 47549097069 scopus 로고    scopus 로고
    • Epoetin-associated pure red cell aplasia: Past, present, and future considerations
    • McKoy JM, Stonecash RE, Cournoyer D, et al. (2008). Epoetin-associated pure red cell aplasia: past, present, and future considerations. Transfusion, 48, 1754-1762.
    • (2008) Transfusion , vol.48 , pp. 1754-1762
    • McKoy, J.M.1    Stonecash, R.E.2    Cournoyer, D.3
  • 65
    • 84879653689 scopus 로고    scopus 로고
    • German Medical Association January Newsletter@akdae.de
    • German Medical Association. (January 2009). Newsletter 2008-2130 Newsletter@akdae.de.
    • (2009) Newsletter , pp. 2008-2130
  • 66
    • 0023588952 scopus 로고
    • A case report of growth attenuation during methionyl human growth hormone treatment
    • Okada Y, Taira K, Takano K, Hizuka N. (1987). A case report of growth attenuation during methionyl human growth hormone treatment. Endocrinol Jpn, 34, 621-626. (Pubitemid 19001414)
    • (1987) Endocrinologia Japonica , vol.34 , Issue.4 , pp. 621-626
    • Okada, Y.1    Taira, K.2    Takano, K.3    Hizuka, N.4
  • 69
    • 77954251975 scopus 로고    scopus 로고
    • Analytical comparisons of erythro-poietin products from Korea and Amgen's Epogen® (epoetin alfa)
    • [abstract]
    • Park S, Patel K, Ko J, et al. (2006). Analytical comparisons of erythro-poietin products from Korea and Amgen's Epogen® (epoetin alfa) [abstract]. Nephrol Dial Transplant, 21, iv14.
    • (2006) Nephrol Dial Transplant , vol.21
    • Park, S.1    Patel, K.2    Ko, J.3
  • 70
    • 0035158301 scopus 로고    scopus 로고
    • Human immune response to recombinant human proteins
    • Porter S. (2001). Human immune response to recombinant human proteins. J Pharm Sci, 90, 1-11.
    • (2001) J Pharm Sci , vol.90 , pp. 1-11
    • Porter, S.1
  • 71
    • 85069240330 scopus 로고    scopus 로고
    • PRCA Update. [cited June 1, 2007]. Last accessed December 4, 2009
    • PRCA Update. (2007). [cited June 1, 2007]. http://www.amgen.com/patients/ prca.html (Last accessed December 4, 2009).
    • (2007)
  • 72
    • 0345059073 scopus 로고    scopus 로고
    • Te detection of anti-erythropoi-etin antibodies in human serum and plasma. Part I. Validation of the protocol for a radioimmunoprecipitation assay
    • Richard Tacey R, Greway A, Smiell J, Power D, Kromminga A, Daha M, Casadevall N, Kelley M. (2003). Te detection of anti-erythropoi-etin antibodies in human serum and plasma. Part I. Validation of the protocol for a radioimmunoprecipitation assay. J Immunol Methods, 283:317-329
    • (2003) J Immunol Methods , vol.283 , pp. 317-329
    • Richard Tacey, R.1    Greway, A.2    Smiell, J.3    Power, D.4    Kromminga, A.5    Daha, M.6    Casadevall, N.7    Kelley, M.8
  • 73
    • 35348872031 scopus 로고    scopus 로고
    • Efcacy and safety of a new ready-to-use recombinant human growth hormone solution
    • Romer T, Peter F, Saenger P, et al. (2007). Efcacy and safety of a new ready-to-use recombinant human growth hormone solution. J Endocrinol Invest, 30, 578-589.
    • (2007) J Endocrinol Invest , vol.30 , pp. 578-589
    • Romer, T.1    Peter, F.2    Saenger, P.3
  • 74
    • 33748041958 scopus 로고    scopus 로고
    • Efects of protein aggregates: An immunologic perspective
    • Rosenberg RS. (2006). Efects of protein aggregates: an immunologic perspective. AAPS J, 8, E501-E507.
    • (2006) AAPS J , vol.8
    • Rosenberg, R.S.1
  • 75
    • 0023645520 scopus 로고
    • Carbohydrate structure of erythropoietin expressed in Chinese hamster ovary cells by a human erythropoietin cDNA
    • Sasaki H, Bothner B, Dell A, Fukuda M. (1987). Carbohydrate structure of erythropoietin expressed in Chinese hamster ovary cells by a human erythropoietin cDNA. J Biol Chem, 262, 12059-12076.
    • (1987) J Biol Chem , vol.262 , pp. 12059-12076
    • Sasaki, H.1    Bothner, B.2    Dell, A.3    Fukuda, M.4
  • 76
    • 19044374719 scopus 로고    scopus 로고
    • Biosimilar epoetins: How similar are they?
    • Schellekens H. (2004). Biosimilar epoetins: how similar are they? Eur J Hosp Pharm Sci, 3, 43-47.
    • (2004) Eur J Hosp Pharm Sci , vol.3 , pp. 43-47
    • Schellekens, H.1
  • 77
    • 32944459736 scopus 로고    scopus 로고
    • Factors infuencing the immunogenicity of therapeutic proteins
    • Schellekens H. (2005). Factors infuencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant, 20(Suppl 6), vi3-vi9.
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 6
    • Schellekens, H.1
  • 78
    • 52649084303 scopus 로고    scopus 로고
    • Recombinant human erythropoietins, biosim-ilars and immunogenicity
    • Schellekens H. (2008a). Recombinant human erythropoietins, biosim-ilars and immunogenicity. J Nephrol, 21, 497-502.
    • (2008) J Nephrol , vol.21 , pp. 497-502
    • Schellekens, H.1
  • 79
    • 38749140300 scopus 로고    scopus 로고
    • Te frst biosimilar epoetin: But how similar is it?
    • Schellekens H. (2008b). Te frst biosimilar epoetin: but how similar is it? Clin J Am Soc Nephrol, 3, 174-178.
    • (2008) Clin J Am Soc Nephrol , vol.3 , pp. 174-178
    • Schellekens, H.1
  • 80
    • 69449095403 scopus 로고    scopus 로고
    • Biosimilar therapeutics-what do we need to consider?
    • Schellekens H. (2009). Biosimilar therapeutics-what do we need to consider? NDT Plus, 2, i27-i36.
    • (2009) NDT Plus , vol.2
    • Schellekens, H.1
  • 81
    • 3242892400 scopus 로고    scopus 로고
    • Immunogenicity of recombinant human proteins: Causes and consequences
    • Schellekens H, Casadevall N. (2004). Immunogenicity of recombinant human proteins: causes and consequences. J Neurol, 251(Suppl 2), II4-II9.
    • (2004) J Neurol , vol.251 , Issue.SUPPL. 2
    • Schellekens, H.1    Casadevall, N.2
  • 82
    • 33745096842 scopus 로고    scopus 로고
    • Eprex-associated pure red cell apla-sia and leachates
    • Schellekens H, Jiskoot W. (2006). Eprex-associated pure red cell apla-sia and leachates. Nat Biotechnol, 24, 613-614.
    • (2006) Nat Biotechnol , vol.24 , pp. 613-614
    • Schellekens, H.1    Jiskoot, W.2
  • 83
    • 51349137409 scopus 로고    scopus 로고
    • Toward biosimilar monoclonal antibodies
    • Schneider CK, Kalinke U. (2008). Toward biosimilar monoclonal antibodies. Nat Biotechnol, 26, 985-990.
    • (2008) Nat Biotechnol , vol.26 , pp. 985-990
    • Schneider, C.K.1    Kalinke, U.2
  • 84
    • 0034545719 scopus 로고    scopus 로고
    • Quantifcation and signifcance of protein oxidation in biological samples
    • Shacter E. (2000). Quantifcation and signifcance of protein oxidation in biological samples. Drug Metab Rev, 32, 307-326.
    • (2000) Drug Metab Rev , vol.32 , pp. 307-326
    • Shacter, E.1
  • 85
    • 0035895071 scopus 로고    scopus 로고
    • Sugar profling proves that human serum erythropoietin difers from recombinant human erythropoietin
    • Skibeli V, Nissen-Lie G, Torjesen P. (2001). Sugar profling proves that human serum erythropoietin difers from recombinant human erythropoietin. Blood, 98, 3626-3634.
    • (2001) Blood , vol.98 , pp. 3626-3634
    • Skibeli, V.1    Nissen-Lie, G.2    Torjesen, P.3
  • 86
    • 0023893064 scopus 로고
    • Resistance to recom-binant interferon alfa-2a in hairy-cell leukemia associated with neutralizing anti-interferon antibodies
    • Steis RG, Smith JW II, Urba WJ, et al. (1988). Resistance to recom-binant interferon alfa-2a in hairy-cell leukemia associated with neutralizing anti-interferon antibodies. N Engl J Med, 318, 1409-1413.
    • (1988) N Engl J Med , vol.318 , pp. 1409-1413
    • Steis, R.G.1    Smith, J.W.I.I.2    Urba, W.J.3
  • 87
    • 21344439335 scopus 로고    scopus 로고
    • Antibody-mediated pure red cell aplasia due to epoetin alfa during antiviral therapy of chronic hepatitis C
    • Stravitz RT, Chung H, Sterling RK, et al. (2005). Antibody-mediated pure red cell aplasia due to epoetin alfa during antiviral therapy of chronic hepatitis C. Am J Gastroenterol, 100, 1415-1419.
    • (2005) Am J Gastroenterol , vol.100 , pp. 1415-1419
    • Stravitz, R.T.1    Chung, H.2    Sterling, R.K.3
  • 89
    • 1842611598 scopus 로고    scopus 로고
    • Evaluation of methods to detect and characterize antibodies against recombinant human erythropoietin
    • Swanson SJ, Ferbas J, Mayeux P, Casadevall N. (2004). Evaluation of methods to detect and characterize antibodies against recombinant human erythropoietin. Nephron Clin Pract, 96, c88-c95.
    • (2004) Nephron Clin Pract , vol.96
    • Swanson, S.J.1    Ferbas, J.2    Mayeux, P.3    Casadevall, N.4
  • 90
    • 33746439001 scopus 로고    scopus 로고
    • Paternal use of ribavirin-interferon alpha 2B combination therapy before conception
    • Taguchi N, Ito S. (2005). Paternal use of ribavirin-interferon alpha 2B combination therapy before conception. Can Fam Physician, 51, 1623-1625.
    • (2005) Can Fam Physician , vol.51 , pp. 1623-1625
    • Taguchi, N.1    Ito, S.2
  • 91
    • 0024563760 scopus 로고
    • Turner's syndrome: Treatment of 203 patients with recombinant human growth hormone for one year. A multicentre study
    • Takano K, Shizume K, Hibi I. (1989). Turner's syndrome: treatment of 203 patients with recombinant human growth hormone for one year. A multicentre study. Acta Endocrinol, 120, 559-568.
    • (1989) Acta Endocrinol , vol.120 , pp. 559-568
    • Takano, K.1    Shizume, K.2    Hibi, I.3
  • 92
    • 20144384746 scopus 로고    scopus 로고
    • Rationally engineered therapeutic proteins with reduced immunogenicity
    • Tangri S, Mothé BR, Eisenbraun J, et al. (2005). Rationally engineered therapeutic proteins with reduced immunogenicity. J Immunol, 174, 3187-3196.
    • (2005) J Immunol , vol.174 , pp. 3187-3196
    • Tangri, S.1    Mothé, B.R.2    Eisenbraun, J.3
  • 93
    • 11844291300 scopus 로고    scopus 로고
    • Protein aggregation and its inhibition in biopharma-ceutics
    • Wang W. (2005). Protein aggregation and its inhibition in biopharma-ceutics. Int J Pharm, 289, 1-30.
    • (2005) Int J Pharm , vol.289 , pp. 1-30
    • Wang, W.1
  • 94
    • 0036707892 scopus 로고    scopus 로고
    • Allergic skin and systemic reactions in a patient with pure red cell apla-sia and anti-erythropoietin antibodies challenged with diferent epoetins
    • Weber G, Gross J, Kromminga A, Loew HH, Eckardt KU. (2002). Allergic skin and systemic reactions in a patient with pure red cell apla-sia and anti-erythropoietin antibodies challenged with diferent epoetins. J Am Soc Nephrol, 13, 2381-2383.
    • (2002) J Am Soc Nephrol , vol.13 , pp. 2381-2383
    • Weber, G.1    Gross, J.2    Kromminga, A.3    Loew, H.H.4    Eckardt, K.U.5
  • 95
    • 0023732647 scopus 로고
    • Clinical experience with Genotropin in growth hormone defcient children
    • Wilton P, Gunnarsson R. (1988). Clinical experience with Genotropin in growth hormone defcient children. Acta Paediatr Scand Suppl, 343, 95-101.
    • (1988) Acta Paediatr Scand Suppl , vol.343 , pp. 95-101
    • Wilton, P.1    Gunnarsson, R.2
  • 96
    • 34447636387 scopus 로고    scopus 로고
    • Hematide is immu-nologically distinct from erythropoietin and corrects anemia induced by antierythropoietin antibodies in a rat pure red cell aplasia model
    • Woodburn KW, Fan Q, Winslow S, et al. (2007). Hematide is immu-nologically distinct from erythropoietin and corrects anemia induced by antierythropoietin antibodies in a rat pure red cell aplasia model. Exp Hematol, 35, 1201-1208.
    • (2007) Exp Hematol , vol.35 , pp. 1201-1208
    • Woodburn, K.W.1    Fan, Q.2    Winslow, S.3


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