메뉴 건너뛰기




Volumn 29, Issue 4, 2015, Pages 285-300

An Integrated Approach for a Structural and Functional Evaluation of Biosimilars: Implications for Erythropoietin

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; GAMMA INTERFERON; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; INTERLEUKIN 13; INTERLEUKIN 3; INTERLEUKIN 4; INTERLEUKIN 5; INTERLEUKIN 6; LEUKEMIA INHIBITORY FACTOR; NERVE GROWTH FACTOR; PROTEIN; RECOMBINANT ERYTHROPOIETIN; STEM CELL FACTOR; TRYPSIN; TUMOR NECROSIS FACTOR ALPHA; ANTIANEMIC AGENT; RECOMBINANT PROTEIN;

EID: 84941425068     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-015-0136-3     Document Type: Article
Times cited : (31)

References (46)
  • 1
    • 84925221941 scopus 로고    scopus 로고
    • Biosimilars: The need, the challenge, the future: The FDA perspective
    • FDA-Related Matters Committee of the American College of Gastroenterology
    • Epstain MS, Ehrenpreis ED, Kulkarni PM, FDA-Related Matters Committee of the American College of Gastroenterology. Biosimilars: the need, the challenge, the future: the FDA perspective. Am J Gastroenterol. 2014;109:1856-9.
    • (2014) Am J Gastroenterol , vol.109 , pp. 1856-1859
    • Epstain, M.S.1    Ehrenpreis, E.D.2    Kulkarni, P.M.3
  • 2
    • 84941413059 scopus 로고    scopus 로고
    • European Medicines Agency Accessed 26 May 2015
    • European Medicines Agency. Biological medicinal products. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/Brochure/2011/03/WC500104227.pdf. Accessed 26 May 2015.
    • (2013) Biological Medicinal Products
  • 3
    • 33644952525 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency CHMP/437/04 Rev 1 Accessed 26 May 2015
    • Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency. Guideline on similar biological medicinal products. CHMP/437/04 Rev 1. 2014. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2014/10/WC500176768.pdf. Accessed 26 May 2015.
    • (2014) Guideline on Similar Biological Medicinal Products
  • 6
    • 84906572793 scopus 로고    scopus 로고
    • Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: A simulation for the EU G5 countries
    • Abraham I, Han L, Sun D, MacDonald K, Aapro M. Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries. Future Oncol. 2014;10(9):1599-609. doi: 10.2217/fon.14.43.
    • (2014) Future Oncol , vol.10 , Issue.9 , pp. 1599-1609
    • Abraham, I.1    Han, L.2    Sun, D.3    MacDonald, K.4    Aapro, M.5
  • 7
    • 84911401436 scopus 로고    scopus 로고
    • Biosimilars: The science of extrapolation
    • Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22):3191-6. doi: 10.1182/blood-2014-06-583617.
    • (2014) Blood , vol.124 , Issue.22 , pp. 3191-3196
    • Weise, M.1    Kurki, P.2    Wolff-Holz, E.3    Bielsky, M.C.4    Schneider, C.K.5
  • 8
    • 84921918300 scopus 로고    scopus 로고
    • Biosimilar versus patented rhEPO: Learning from 5 years of European and Japanese experience
    • Bocquet F, Paubel P, Fusier I, Cordonnier AL, Sinègre M, Le Pen C. Biosimilar versus patented erythropoietins: learning from 5 years of European and Japanese experience. Appl Health Econ Health Policy. 2015;13(1):47-59. doi: 10.1007/s40258-014-0125-6.
    • (2015) Appl Health Econ Health Policy , vol.13 , Issue.1 , pp. 47-59
    • Bocquet, F.1    Paubel, P.2    Fusier, I.3    Cordonnier, A.L.4    Sinègre, M.5    Le Pen, C.6
  • 9
    • 84863218474 scopus 로고    scopus 로고
    • Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars
    • Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012;11(7):527-40. doi: 10.1038/nrd3746.
    • (2012) Nat Rev Drug Discov , vol.11 , Issue.7 , pp. 527-540
    • Berkowitz, S.A.1    Engen, J.R.2    Mazzeo, J.R.3    Jones, G.B.4
  • 10
    • 0026019106 scopus 로고
    • Erythropoietin
    • 1:CAS:528:DyaK3MXltVKisb0%3D 1991159
    • Krantz SB. Erythropoietin. Blood. 1991;77:419-34.
    • (1991) Blood , vol.77 , pp. 419-434
    • Krantz, S.B.1
  • 11
    • 0021978919 scopus 로고
    • Isolation and characterization of genomic and cDNA clones of human erythropoietin
    • Jacobs K, Shoemaker C, Rudersdorf R, Neill SD, Kaufman RJ, Seehra J, et al. Isolation and characterization of genomic and cDNA clones of human erythropoietin. Nature. 1985;313(6005):806-10. doi: 10.1038/313806a0.
    • (1985) Nature , vol.313 , Issue.6005 , pp. 806-810
    • Jacobs, K.1    Shoemaker, C.2    Rudersdorf, R.3    Neill, S.D.4    Kaufman, R.J.5    Seehra, J.6
  • 13
    • 84890517373 scopus 로고    scopus 로고
    • Glycosylation characterization of recombinant human erythropoietin produced in glycoengineered Pichia pastoris by mass spectrometry
    • Gong B, Burnina I, Stadhein TA, Li H. Glycosylation characterization of recombinant human erythropoietin produced in glycoengineered Pichia pastoris by mass spectrometry. J Mass Spectrom. 2013;48(12):1308-17. doi: 10.1002/jms.3291.
    • (2013) J Mass Spectrom , vol.48 , Issue.12 , pp. 1308-1317
    • Gong, B.1    Burnina, I.2    Stadhein, T.A.3    Li, H.4
  • 14
    • 0023849601 scopus 로고
    • Comparative study of the asparagine-linked sugar chains of human erythropoietins purified from urine and the culture medium of recombinant Chinese hamster ovary cells
    • 1:CAS:528:DyaL1cXitFKntrg%3D 3346214
    • Takeuchi M, Takasaki S, Miyazaki H, Kato T, Hoshi S, Kochibe N, et al. Comparative study of the asparagine-linked sugar chains of human erythropoietins purified from urine and the culture medium of recombinant Chinese hamster ovary cells. J Biol Chem. 1988;263:3657-63.
    • (1988) J Biol Chem , vol.263 , pp. 3657-3663
    • Takeuchi, M.1    Takasaki, S.2    Miyazaki, H.3    Kato, T.4    Hoshi, S.5    Kochibe, N.6
  • 15
    • 0024270999 scopus 로고
    • Glycosylation at specific sites of erythropoietin is essential for biosynthesis, secretion, and biological function
    • 1:CAS:528:DyaL1cXlvVelt7Y%3D 3182860
    • Dube S, Fisher JW, Powell JS. Glycosylation at specific sites of erythropoietin is essential for biosynthesis, secretion, and biological function. J Biol Chem. 1988;263:17516-21.
    • (1988) J Biol Chem , vol.263 , pp. 17516-17521
    • Dube, S.1    Fisher, J.W.2    Powell, J.S.3
  • 16
    • 0024497455 scopus 로고
    • Survival of recombinant erythropoietin in the circulation: The role of carbohydrates
    • 1:CAS:528:DyaL1MXovFeruw%3D%3D 2910371
    • Fukuda MN, Sasaki H, Lopez L, Fukuda M. Survival of recombinant erythropoietin in the circulation: the role of carbohydrates. Blood. 1989;73:84-9.
    • (1989) Blood , vol.73 , pp. 84-89
    • Fukuda, M.N.1    Sasaki, H.2    Lopez, L.3    Fukuda, M.4
  • 17
    • 0035895071 scopus 로고    scopus 로고
    • Sugar profiling proves that human serum erythropoietin differs from recombinant human erythropoietin
    • Skibeli V, Nissen-Lie G, Torjesen P. Sugar profiling proves that human serum erythropoietin differs from recombinant human erythropoietin. Blood. 2001;8(13):3626-34. doi: 10.1182/blood.V98.13.3626.
    • (2001) Blood , vol.8 , Issue.13 , pp. 3626-3634
    • Skibeli, V.1    Nissen-Lie, G.2    Torjesen, P.3
  • 18
    • 10044237889 scopus 로고    scopus 로고
    • Control of rHuEPO biological activity: The role of carbohydrate
    • Elliott S, Egrie J, Browne J, Lorenzini T, Busse L, Rogers N, et al. Control of rHuEPO biological activity: the role of carbohydrate. Exp Hematol. 2004;32(12):1146-55. doi: 10.1016/j.exphem.2004.08.004.
    • (2004) Exp Hematol , vol.32 , Issue.12 , pp. 1146-1155
    • Elliott, S.1    Egrie, J.2    Browne, J.3    Lorenzini, T.4    Busse, L.5    Rogers, N.6
  • 19
    • 84884901120 scopus 로고    scopus 로고
    • Epoetin biosimilars in Europe: Five years on
    • Mikhail A, Farouk M. Epoetin biosimilars in Europe: five years on. Adv Ther. 2013;30(1):28-40. doi: 10.1007/s12325-012-0072-2.
    • (2013) Adv Ther , vol.30 , Issue.1 , pp. 28-40
    • Mikhail, A.1    Farouk, M.2
  • 20
    • 84941414394 scopus 로고    scopus 로고
    • EMA Accessed 22 Jan 2015
    • EMA. Epoetin alfa: EPAR - Scientific discussion. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Scientific-Discussion/human/000725/WC500053615.pdf. Accessed 22 Jan 2015.
    • Epoetin Alfa: EPAR - Scientific Discussion
  • 21
    • 84856728382 scopus 로고    scopus 로고
    • EMA Accessed 22 Jan 2015
    • EMA. Retacrit: EPAR - Scientific discussion. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Scientific-Discussion/human/000872/WC500054374.pdf. Accessed 22 Jan 2015.
    • Retacrit: EPAR - Scientific Discussion
  • 22
    • 84941426542 scopus 로고    scopus 로고
    • Reporter US Sigma-Aldrich Accessed 17 Aug 2015
    • Stenerson KK. The derivatization and analysis of amino acids by GC-MS. Reporter US Volume 25.3. Sigma-Aldrich. https://www.sigmaaldrich.com/content/dam/sigma-aldrich/articles/reporter-us/pdf/the-derivatization.pdf. Accessed 17 Aug 2015.
    • The Derivatization and Analysis of Amino Acids by GC-MS , vol.25 , Issue.3
    • Stenerson, K.K.1
  • 23
    • 0029927505 scopus 로고    scopus 로고
    • Mass spectrometric sequencing of proteins silver-stained polyacrylamide gels
    • Shevchenko A, Wilm M, Vorm O, Mann M. Mass spectrometric sequencing of proteins silver-stained polyacrylamide gels. Anal Chem. 1996;68(5):850-8. doi: 10.1021/ac950914h.
    • (1996) Anal Chem , vol.68 , Issue.5 , pp. 850-858
    • Shevchenko, A.1    Wilm, M.2    Vorm, O.3    Mann, M.4
  • 24
    • 77956333493 scopus 로고    scopus 로고
    • Secretome analysis of multiple pancreatic cancer cell lines reveals perturbations of key functional networks
    • 1:CAS:528:DC%2BC3cXpslGqt7o%3D 20687567
    • Schiarea S, Solinas G, Allavena P, Scigliuolo GM, Bagnati R, Fanelli R, et al. Secretome analysis of multiple pancreatic cancer cell lines reveals perturbations of key functional networks. J Proteome Res. 2010;9:4376-92.
    • (2010) J Proteome Res , vol.9 , pp. 4376-4392
    • Schiarea, S.1    Solinas, G.2    Allavena, P.3    Scigliuolo, G.M.4    Bagnati, R.5    Fanelli, R.6
  • 26
    • 0035865186 scopus 로고    scopus 로고
    • The vascular anatomy of the developing zebrafish: An atlas of embryonic and early larval development
    • Isogai S, Horiguchi M, Weinstein BM. The vascular anatomy of the developing zebrafish: an atlas of embryonic and early larval development. Dev Biol. 2001;230(2):278-301. doi: 10.1006/dbio.2000.9995.
    • (2001) Dev Biol , vol.230 , Issue.2 , pp. 278-301
    • Isogai, S.1    Horiguchi, M.2    Weinstein, B.M.3
  • 27
    • 34548133233 scopus 로고    scopus 로고
    • The zebrafish erythropoietin: Functional identification and biochemical characterization
    • Chu CY, Cheng CH, Chen GD, Chen YC, Hung CC, Huang KY, et al. The zebrafish erythropoietin: functional identification and biochemical characterization. FEBS Lett. 2007;581(22):4265-71. doi: 10.1016/j.febslet.2007.07.073.
    • (2007) FEBS Lett , vol.581 , Issue.22 , pp. 4265-4271
    • Chu, C.Y.1    Cheng, C.H.2    Chen, G.D.3    Chen, Y.C.4    Hung, C.C.5    Huang, K.Y.6
  • 28
    • 30344457882 scopus 로고    scopus 로고
    • Regulation of primitive hematopoiesis in zebrafish embryos by the death receptor gene
    • Kwan TT, Liang R, Verfaillie CM, Ekker SC, Chan LC, Lin S, et al. Regulation of primitive hematopoiesis in zebrafish embryos by the death receptor gene. Exp Hematol. 2006;34(1):27-34. doi: 10.1016/j.exphem.2005.09.017.
    • (2006) Exp Hematol , vol.34 , Issue.1 , pp. 27-34
    • Kwan, T.T.1    Liang, R.2    Verfaillie, C.M.3    Ekker, S.C.4    Chan, L.C.5    Lin, S.6
  • 29
    • 38049115783 scopus 로고    scopus 로고
    • Origins and unconventional behavior of neutrophils in developing zebrafish
    • Le Guyader D, Redd MJ, Colucci-Guyon E, Murayama E, Kissa K, Briolat V, et al. Origins and unconventional behavior of neutrophils in developing zebrafish. Blood. 2008;111(1):132-41. doi: 10.1182/2007-06-095398.
    • (2008) Blood , vol.111 , Issue.1 , pp. 132-141
    • Le Guyader, D.1    Redd, M.J.2    Colucci-Guyon, E.3    Murayama, E.4    Kissa, K.5    Briolat, V.6
  • 30
    • 38149126474 scopus 로고    scopus 로고
    • High-resolution in situ hybridization to whole-mount zebrafish embryos
    • Thisse C, Thisse B. High-resolution in situ hybridization to whole-mount zebrafish embryos. Nat Protoc. 2008;3(1):59-69. doi: 10.1038/nprot.2007.514.
    • (2008) Nat Protoc , vol.3 , Issue.1 , pp. 59-69
    • Thisse, C.1    Thisse, B.2
  • 31
    • 0037420210 scopus 로고    scopus 로고
    • Matrix-assisted laser-desorption time-of flight ionisation and high-performance liquid chromatography-electrospray ionisation mass spectral analyses of two glycosylated recombinant epoetins
    • Stanley SMR, Poljak A. Matrix-assisted laser-desorption time-of flight ionisation and high-performance liquid chromatography-electrospray ionisation mass spectral analyses of two glycosylated recombinant epoetins. J Chromatogr B Analyt Technol Biomed Life Sci. 2003;785(2):205-18. doi: 10.1016/S1570-0232(02)00824-3.
    • (2003) J Chromatogr B Analyt Technol Biomed Life Sci , vol.785 , Issue.2 , pp. 205-218
    • Stanley, S.M.R.1    Poljak, A.2
  • 32
    • 84874175946 scopus 로고    scopus 로고
    • Gel electrophoretic methods for the analysis of biosimilar pharmaceuticals using the example of recombinant erythropoietin
    • Reichel C, Thevis M. Gel electrophoretic methods for the analysis of biosimilar pharmaceuticals using the example of recombinant erythropoietin. Bioanalysis. 2013;5(5):587-602. doi: 10.4155/BIO.13.9.
    • (2013) Bioanalysis , vol.5 , Issue.5 , pp. 587-602
    • Reichel, C.1    Thevis, M.2
  • 34
    • 2542640024 scopus 로고    scopus 로고
    • Protein identification by mass spectrometry - Issues to be considered
    • Baldwin MA. Protein identification by mass spectrometry - issues to be considered. Mol Cell Proteomics. 2004;3(1):1-9. doi: 10.1074/mcp.R300012-MCP200.
    • (2004) Mol Cell Proteomics , vol.3 , Issue.1 , pp. 1-9
    • Baldwin, M.A.1
  • 35
    • 27544475447 scopus 로고    scopus 로고
    • Simple modification of a protein database for mass spectral identification of N-linked glycopeptides
    • Atwood JA 3rd, Sahoo SS, Alvarez-Manilla G, Weatherly DB, Kolli K, Orlando R, et al. Simple modification of a protein database for mass spectral identification of N-linked glycopeptides. Rapid Commun Mass Spectrom. 2005;19(21):3002-6. doi: 10.1002/rcm.2162.
    • (2005) Rapid Commun Mass Spectrom , vol.19 , Issue.21 , pp. 3002-3006
    • Atwood, J.A.1    Sahoo, S.S.2    Alvarez-Manilla, G.3    Weatherly, D.B.4    Kolli, K.5    Orlando, R.6
  • 36
    • 0034307524 scopus 로고    scopus 로고
    • Application of liquid chromatography/mass spectrometry and liquid chromatography with tandem mass spectrometry to the analysis of the site-specific carbohydrate heterogeneity in erythropoietin
    • Kawasaki N, Ohta M, Hyuga S, Hyuga M, Hayakawa T. Application of liquid chromatography/mass spectrometry and liquid chromatography with tandem mass spectrometry to the analysis of the site-specific carbohydrate heterogeneity in erythropoietin. Anal Biochem. 2000;285(1):82-91. doi: 10.1006/abio.2000.4739.
    • (2000) Anal Biochem , vol.285 , Issue.1 , pp. 82-91
    • Kawasaki, N.1    Ohta, M.2    Hyuga, S.3    Hyuga, M.4    Hayakawa, T.5
  • 37
    • 0022003140 scopus 로고
    • Deglycosylation of asparagine-linked glycans by peptide:N-glycosidase-F
    • Tarentino AL, Gomez CM, Plummer TH. Deglycosylation of asparagine-linked glycans by peptide:N-glycosidase-F. Biochemistry. 1985;24(17):4665-71. doi: 10.1021/bi00338a028.
    • (1985) Biochemistry , vol.24 , Issue.17 , pp. 4665-4671
    • Tarentino, A.L.1    Gomez, C.M.2    Plummer, T.H.3
  • 39
    • 10744224654 scopus 로고    scopus 로고
    • Epoetin alfa, epoetin beta and darbepoetin alfa: Two-dimensional gel electrophoresis isoforms characterization and mass spectrometry analysis
    • Caldini A, Moneti G, Fanelli A, Bruschettini A, Mercurio S, Pieraccini G, et al. Epoetin alfa, epoetin beta and darbepoetin alfa: two-dimensional gel electrophoresis isoforms characterization and mass spectrometry analysis. Proteomics. 2003;3(6):937-41. doi: 10.1002/pmic.200300405.
    • (2003) Proteomics , vol.3 , Issue.6 , pp. 937-941
    • Caldini, A.1    Moneti, G.2    Fanelli, A.3    Bruschettini, A.4    Mercurio, S.5    Pieraccini, G.6
  • 40
    • 0024318485 scopus 로고
    • Establishment and characterization of a unique human cell line that proliferates dependently on GM-CSF, IL-3, or erythropoietin
    • Kitamura T, Tange T, Terasawa T, Chiba S, Kuwaki T, Miyacawa K, et al. Establishment and characterization of a unique human cell line that proliferates dependently on GM-CSF, IL-3, or erythropoietin. J Cell Physiol. 1989;140(2):323-34. doi: 10.1002/jcp.1041400219.
    • (1989) J Cell Physiol , vol.140 , Issue.2 , pp. 323-334
    • Kitamura, T.1    Tange, T.2    Terasawa, T.3    Chiba, S.4    Kuwaki, T.5    Miyacawa, K.6
  • 41
    • 0030392279 scopus 로고    scopus 로고
    • Regulation of expression of the human erythropoietin receptor gene
    • Winter SS, Howard T, Ware RE. Regulation of expression of the human erythropoietin receptor gene. Blood Cell Mol Dis. 1996;22(3):214-24. doi: 10.1006/bcmd.1996.0102 (discussion 224a).
    • (1996) Blood Cell Mol Dis. , vol.22 , Issue.3 , pp. 214-224
    • Winter, S.S.1    Howard, T.2    Ware, R.E.3
  • 42
    • 0028851950 scopus 로고
    • Quantitative cell line based bioassays for human cytokines
    • Miresluis AR, Page L, Thorpe R. Quantitative cell line based bioassays for human cytokines. J Immunol Methods. 1995;187(2):191-9. doi: 10.1016/0022-1759(95)00220-1.
    • (1995) J Immunol Methods , vol.187 , Issue.2 , pp. 191-199
    • Miresluis, A.R.1    Page, L.2    Thorpe, R.3
  • 43
    • 17344372251 scopus 로고    scopus 로고
    • Terminal megakaryocytic differentiation of TF-1 cells is induced by phorbol esters and thrombopoietin and is blocked by expression of PML/RAR alfa fusion protein
    • Testa U, Grignani F, Hassan HJ, Rogaia D, Masciulli R, Gelmetti V, et al. Terminal megakaryocytic differentiation of TF-1 cells is induced by phorbol esters and thrombopoietin and is blocked by expression of PML/RAR alfa fusion protein. Leukemia. 1998;12(4):563-70. doi: 10.1038/sj.leu.2400967.
    • (1998) Leukemia , vol.12 , Issue.4 , pp. 563-570
    • Testa, U.1    Grignani, F.2    Hassan, H.J.3    Rogaia, D.4    Masciulli, R.5    Gelmetti, V.6
  • 44
    • 0041817808 scopus 로고    scopus 로고
    • Zebrafish: A new model on the pharmaceutical catwalk
    • Langheinrich U. Zebrafish: a new model on the pharmaceutical catwalk. BioEssays. 2003;25(9):904-12. doi: 10.1002/bies.10326.
    • (2003) BioEssays , vol.25 , Issue.9 , pp. 904-912
    • Langheinrich, U.1
  • 45
    • 79959659104 scopus 로고    scopus 로고
    • Zebrafish as a model for normal and malignant hematopoiesis
    • Jing L, Zon LI. Zebrafish as a model for normal and malignant hematopoiesis. Dis Model Mech. 2011;4(4):433-8. doi: 10.1242/dmm.006791.
    • (2011) Dis Model Mech. , vol.4 , Issue.4 , pp. 433-438
    • Jing, L.1    Zon, L.I.2
  • 46
    • 69249158143 scopus 로고    scopus 로고
    • Zebrafish blood stem cells
    • Chen AT, Zon LI. Zebrafish blood stem cells. J Cell Biochem. 2009;108(1):35-42. doi: 10.1002/jcb.22251.
    • (2009) J Cell Biochem , vol.108 , Issue.1 , pp. 35-42
    • Chen, A.T.1    Zon, L.I.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.