-
1
-
-
33746169811
-
Biosimilars: How similar or dissimilar are they?
-
Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology 2006;11:341-346
-
(2006)
Nephrology
, vol.11
, pp. 341-346
-
-
Roger, S.D.1
-
2
-
-
0036499495
-
'Biogenerics': The off-patent biotech products
-
Schellekens H, Ryff JC. 'Biogenerics': the off-patent biotech products. Trends Pharmacol Sci 2002;23:119-121
-
(2002)
Trends Pharmacol Sci
, vol.23
, pp. 119-121
-
-
Schellekens, H.1
Ryff, J.C.2
-
3
-
-
33748685217
-
Comparative testing and pharmacovigilance of biosimilars
-
Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant 2006;21(suppl 5):v13-v6.
-
(2006)
Nephrol Dial Transplant
, vol.21
, Issue.SUPPL 5
-
-
Locatelli, F.1
Roger, S.2
-
4
-
-
33748687181
-
The protein science of biosimilars
-
Kuhlmann M, Covic A. The protein science of biosimilars. Nephrol Dial Transplant 2006;21(suppl 5):v4-8.
-
(2006)
Nephrol Dial Transplant
, vol.21
, Issue.SUPPL 5
-
-
Kuhlmann, M.1
Covic, A.2
-
5
-
-
77952517799
-
-
European Medicines Agency. International Conference on Harmonization Topic Q6B: Specifications: test procedures and acceptance criteria for biotechnological/biological products. Document # CPMP/ICH/365/96. September. London: EMEA 1999. (Accessed 2 September)
-
European Medicines Agency. International Conference on Harmonization Topic Q6B: Specifications: test procedures and acceptance criteria for biotechnological/biological products. Document # CPMP/ICH/365/96. September 1999. London: EMEA, 1999. www.emea.europa.eu/pdfs/human/ich/036596en.pdf. (Accessed 2 September 2009)
-
(1999)
-
-
-
6
-
-
33748707376
-
European regulatory guidelines for biosimilars
-
Wiecek A, Mikhail A. European regulatory guidelines for biosimilars. Nephrol Dial Transplant 2006;21(suppl 5):v17-20.
-
(2006)
Nephrol Dial Transplant
, vol.21
, Issue.SUPPL 5
-
-
Wiecek, A.1
Mikhail, A.2
-
7
-
-
77952513795
-
-
Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products. London: EMEA. (Accessed 13 April)
-
Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products. London: EMEA, 2005. www.emea.europa.eu/pdfs/ human/biosimilar/043704en.pdf. (Accessed 13 April 2009)
-
(2005)
-
-
-
8
-
-
77952530431
-
-
Committee for Medicinal Products for Human Use. Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. London: EMEA. (Accessed 13 April)
-
Committee for Medicinal Products for Human Use. Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. London: EMEA, 2006. www.emea.europa.eu/pdfs/ human/biosimilar/4934805en.pdf. (Accessed 13 April 2009)
-
(2006)
-
-
-
9
-
-
77952502156
-
-
Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London: EMEA. (Accessed 13 April)
-
Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London: EMEA, 2006. www.emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf. (Accessed 13 April 2009)
-
(2006)
-
-
-
10
-
-
77952499257
-
-
Committee for Medicinal Products for Human Use. Annex 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 human insulin. London: EMEA. (Accessed 13 April)
-
Committee for Medicinal Products for Human Use. Annex 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 human insulin. London: EMEA, 2006. www.emea.europa.eu/pdfs/human/biosimilar/3277505en.pdf. (Accessed 13 April 2009)
-
(2006)
-
-
-
11
-
-
77952526466
-
-
European Medicines Agency. 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. London, 22 March. Document ref EMEA/CHMP/BMWP/94526/2005 Corr. London: EMEA 2006. (Accessed 1 May)
-
European Medicines Agency. 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. London, 22 March 2006. Document ref EMEA/CHMP/BMWP/94526/2005 Corr. London: EMEA, 2006. www.emea.europa.eu/ pdfs/human/biosimilar/9452605en.pdf. (Accessed 1 May 2009)
-
(2006)
-
-
-
14
-
-
17844366885
-
Therapeutic insulins and their large-scale manufacture
-
Walsh G. Therapeutic insulins and their large-scale manufacture. Appl Microbiol Biotechnol 2005;67:151-159
-
(2005)
Appl Microbiol Biotechnol
, vol.67
, pp. 151-159
-
-
Walsh, G.1
-
15
-
-
36048991061
-
Insulin: History, biochemistry, physiology and pharmacology
-
Joshi SR, Parikh RM, Das AK. Insulin: history, biochemistry, physiology and pharmacology. J Assoc Physicians India 2007;55(suppl):19-25.
-
(2007)
J Assoc Physicians India
, vol.55
, Issue.SUPPL.
, pp. 19-25
-
-
Joshi, S.R.1
Parikh, R.M.2
Das, A.K.3
-
20
-
-
0021988025
-
Some chemical properties of human erythropoietin
-
Wang FF, Kung CKH, Goldwasser E. Some chemical properties of human erythropoietin. Endocrinology 1985;116:2286-2292
-
(1985)
Endocrinology
, vol.116
, pp. 2286-2292
-
-
Wang, F.F.1
Kung, C.K.H.2
Goldwasser, E.3
-
21
-
-
0022973324
-
Structural characterization of human erythropoietin
-
Lai PH, Everett R, Wang FF. Structural characterization of human erythropoietin. J Biol Chem 1986;261:3116-3121
-
(1986)
J Biol Chem
, vol.261
, pp. 3116-3121
-
-
Lai, P.H.1
Everett, R.2
Wang, F.F.3
-
22
-
-
0034865085
-
Present and future strategies in the treatment of renal anemia
-
Macdougall IC. Present and future strategies in the treatment of renal anemia. Nephrol Dial Transplant 2001;16(suppl 5):50-55
-
(2001)
Nephrol Dial Transplant
, vol.16
, Issue.SUPPL. 5
, pp. 50-55
-
-
MacDougall, I.C.1
-
23
-
-
1442277118
-
Epoetin beta: A review of its clinical use in the treatment of anemia in patients with cancer
-
Cheer SM, Wagstaff AJ. Epoetin beta: a review of its clinical use in the treatment of anemia in patients with cancer. Drugs 2004;64:323-346
-
(2004)
Drugs
, vol.64
, pp. 323-346
-
-
Cheer, S.M.1
Wagstaff, A.J.2
-
25
-
-
10044237889
-
Control of rHuEPO biological activity: The role of carbohydrate
-
Elliott S, Egrie J, Browne J et al. Control of rHuEPO biological activity: the role of carbohydrate. Exp Hematol 2004;32:1146-1155
-
(2004)
Exp Hematol
, vol.32
, pp. 1146-1155
-
-
Elliott, S.1
Egrie, J.2
Browne, J.3
-
26
-
-
36549023117
-
Production of recombinant human erythropoietin from Pichia pastors and its structural analysis
-
Celik E, Calik P, Halloran SM, Oliver SG. Production of recombinant human erythropoietin from Pichia pastors and its structural analysis. J Appl Microbiol 2007;103:2084-2094
-
(2007)
J Appl Microbiol
, vol.103
, pp. 2084-2094
-
-
Celik, E.1
Calik, P.2
Halloran, S.M.3
Oliver, S.G.4
-
27
-
-
67049136571
-
Pharma swept up in biogenerics gold rush
-
Ratner M. Pharma swept up in biogenerics gold rush. Nat Biotechnol 2009;27:299-301.
-
(2009)
Nat Biotechnol
, vol.27
, pp. 299-301
-
-
Ratner, M.1
-
28
-
-
0242490896
-
Biological evaluation of recombinant human erythropoietin in pharmaceutical products
-
Ramos AS, Schmidt CA, Andrade SS et al. Biological evaluation of recombinant human erythropoietin in pharmaceutical products. Braz J Med Biol Res 2003;36:1561-1569
-
(2003)
Braz J Med Biol Res
, vol.36
, pp. 1561-1569
-
-
Ramos, A.S.1
Schmidt, C.A.2
Andrade, S.S.3
-
29
-
-
19044395847
-
Follow-on biologics: Challenges of the "next generation"
-
Schellekens H. Follow-on biologics: challenges of the "next generation". Nephrol Dial Transplant 2005;20(suppl 4):iv31-6.
-
(2005)
Nephrol Dial Transplant
, vol.20
, Issue.SUPPL. 4
-
-
Schellekens, H.1
-
30
-
-
19044374719
-
Biosimilar epoetins: How similar are they?
-
Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm 2004;3:8-12.
-
(2004)
Eur J Hosp Pharm
, vol.3
, pp. 8-12
-
-
Schellekens, H.1
-
31
-
-
0037075272
-
Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
-
DOI 10.1056/NEJMoa011931
-
Casadevall N, Nataf J, Viron B et al. Pure red-cell aplasia and antieryth-ropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002;346:469-475 (Pubitemid 34441737)
-
(2002)
New England Journal of Medicine
, vol.346
, Issue.7
, pp. 469-475
-
-
Casadevall, N.1
Nataf, J.2
Viron, B.3
Kolta, A.4
Kiladjian, J.-J.5
Martin-Dupont, P.6
Michaud, P.7
Papo, T.8
Ugo, V.9
Teyssandier, I.10
Varet, B.11
Mayeux, P.12
-
32
-
-
15844367464
-
Immunologic mechanisms of EPO-associated pure red cell aplasia
-
DOI 10.1016/j.beha.2005.01.016, PII S1521692605000174
-
Schellekens H. Immunologic mechanisms of EPO-associated pure red cell aplasia. Best Pract Res Clin Haematol 2005;18:473-480 (Pubitemid 40425360)
-
(2005)
Best Practice and Research: Clinical Haematology
, vol.18
, Issue.3 SPEC. ISS.
, pp. 473-480
-
-
Schellekens, H.1
-
33
-
-
35748959960
-
Pure red-cell aplasia "epidemic" - Mystery completely revealed?
-
Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia "epidemic" - mystery completely revealed? Perit Dial Int 2007;27(suppl 2):S303-07.
-
(2007)
Perit Dial Int
, vol.27
, Issue.SUPPL. 2
-
-
Locatelli, F.1
Del Vecchio, L.2
Pozzoni, P.3
-
34
-
-
0347477301
-
Micelle- associated protein in epoetin formulations: A risk factor for immuno- genicity?
-
Hermeling S, Schellekens H, Crommelin DJ, Jiskoot W. Micelle- associated protein in epoetin formulations: a risk factor for immuno- genicity? Pharm Res 2003:20:1903-1907
-
(2003)
Pharm Res
, vol.20
, pp. 1903-1907
-
-
Hermeling, S.1
Schellekens, H.2
Crommelin, D.J.3
Jiskoot, W.4
-
35
-
-
19044379264
-
Technical investigations into the cause of the increased incidence of antibody-mediated pure red cell aplasia associated with Eprex
-
Sharma B, Bader F, Templeman T et al. Technical investigations into the cause of the increased incidence of antibody-mediated pure red cell aplasia associated with Eprex. Eur J Hospital Pharm 2004;5:86-91.
-
(2004)
Eur J Hospital Pharm
, vol.5
, pp. 86-91
-
-
Sharma, B.1
Bader, F.2
Templeman, T.3
-
36
-
-
33644546683
-
An in vivo model to assess factors that may stimulate the generation of an immune reaction to erythropoietin
-
Ryan MH, Heavner GA, Brigham-Burke M et al. An in vivo model to assess factors that may stimulate the generation of an immune reaction to erythropoietin. Int Immunopharmacol 2006;6:647-655
-
(2006)
Int Immunopharmacol
, vol.6
, pp. 647-655
-
-
Ryan, M.H.1
Heavner, G.A.2
Brigham-Burke, M.3
-
37
-
-
77952537026
-
Summary of PRCA case reports: Update on the actions by Johnson and Johnson Pharmaceutical Research and Development regarding erythropoietin antibody-positive pure red cell aplasia
-
Johnson and Johnson Pharmaceutical Research and Development
-
Johnson and Johnson Pharmaceutical Research and Development. Summary of PRCA case reports: update on the actions by Johnson and Johnson Pharmaceutical Research and Development regarding erythropoietin antibody-positive pure red cell aplasia. Raritan: Johnson and Johnson Pharmaceutical Research and Development, 2005.
-
(2005)
Raritan: Johnson and Johnson Pharmaceutical Research and Development
-
-
-
38
-
-
15844426701
-
Importance of biologic follow-ons: Experience with EPO. Best Practice & Research
-
Casadevall N, Rossert J. Importance of biologic follow-ons: experience with EPO. Best Practice & Research. Clin Haematol 2005;18:381-387
-
(2005)
Clin Haematol
, vol.18
, pp. 381-387
-
-
Casadevall, N.1
Rossert, J.2
-
39
-
-
52049105653
-
Biosimilars: It's not as simple as cost alone
-
Roger SD, Goldsmith D. Biosimilars: it's not as simple as cost alone. J Clin Pharm Ther 2008:33:459-464
-
(2008)
J Clin Pharm Ther
, vol.33
, pp. 459-464
-
-
Roger, S.D.1
Goldsmith, D.2
-
41
-
-
56749163625
-
Biosimilars and biophar-maceuticals: What the nephrologists need to know - A position paper by the ERA-EDTA Council
-
Covic A, Cannataq-Andia J, Cancarini G et al. Biosimilars and biophar-maceuticals: what the nephrologists need to know - a position paper by the ERA-EDTA Council. Nephrol Dial Transplant 2008;23:3731-3737
-
(2008)
Nephrol Dial Transplant
, vol.23
, pp. 3731-3737
-
-
Covic, A.1
Cannataq-Andia, J.2
Cancarini, G.3
|