-
1
-
-
54349091558
-
Safety-related regulatory actions for biologicals approved in the United States and the European Union
-
Giezen TJ, Mantel-Teeuwisse AK, Straus SM, et al. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 2008;300:1887-1896.
-
(2008)
JAMA
, vol.300
, pp. 1887-1896
-
-
Giezen, T.J.1
Mantel-Teeuwisse, A.K.2
Straus, S.M.3
-
2
-
-
33746169811
-
Biosimilars: How similar or dissimilar are they?
-
DOI 10.1111/j.1440-1797.2006.00594.x
-
Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology (Carlton) 2006;11:341-346. (Pubitemid 44086880)
-
(2006)
Nephrology
, vol.11
, Issue.4
, pp. 341-346
-
-
Roger, S.D.1
-
3
-
-
8344224534
-
Characteristics biological products and assessing comparability following manufacturing changes
-
DOI 10.1038/nbt1030
-
Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 2004;22:1383-1391. (Pubitemid 39482857)
-
(2004)
Nature Biotechnology
, vol.22
, Issue.11
, pp. 1383-1391
-
-
Chirino, A.J.1
Mire-Sluis, A.2
-
4
-
-
32944459736
-
Factors influencing the immunogenicity of therapeutic proteins
-
Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant 2005;20(Suppl 6):vi3-9.
-
(2005)
Nephrol Dial Transplant
, vol.20
, Issue.SUPPL. 6
-
-
Schellekens, H.1
-
5
-
-
34547113855
-
-
Available at: Accessed February 8, 2011
-
Top 20 biologics 2009. Available at: http://www.pipelinereview.com/free- downloads/top-20-biologics-2009-rd-pipeline-news.pdf Accessed February 8, 2011.
-
Top 20 Biologics 2009
-
-
-
6
-
-
33644952525
-
-
Available at: Accessed February 9, 2011
-
European Medicines Agency. Guideline on similar biological medicinal products. 2005. Available at: www.ema.europa.eu/pdfs/human/biosimilar/043704en. pdf. Accessed February 9, 2011.
-
(2005)
Guideline on Similar Biological Medicinal Products
-
-
-
10
-
-
33749345017
-
The market for follow-on biologics: How will it evolve?
-
DOI 10.1377/hlthaff.25.5.1291
-
Grabowski H, Cockburn I, Long G. The market for follow-on biologics: how will it evolve? Health Aff (Millwood) 2006;25:1291-1301. (Pubitemid 44497628)
-
(2006)
Health Affairs
, vol.25
, Issue.5
, pp. 1291-1301
-
-
Grabowski, H.1
Cockburn, I.2
Long, G.3
-
11
-
-
0032799186
-
Overview of the Hatch-Waxman act and its impact on the drug development process
-
Mossinghoff GJ. Overview of the Hatch-Waxman Act and its impact on the drug development process. Food Drug Law J 1999;54:187-194. (Pubitemid 29328042)
-
(1999)
Food and Drug Law Journal
, vol.54
, Issue.2
, pp. 187-194
-
-
Mossinghoff, G.J.1
-
12
-
-
0003922013
-
-
Center for Drug Evalation and Research. Available at: Accessed February 10, 2011
-
Center for Drug Evalation and Research. CDER guidance for industry: statistical approaches to establishing bioequivalence. 2001. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm070244.pdf. Accessed February 10, 2011.
-
(2001)
CDER Guidance for Industry: Statistical Approaches to Establishing Bioequivalence
-
-
-
13
-
-
70449463992
-
Comparing generic and innovator drugs: A review of 12 years of bioequivalence data from the United States Food and Drug Administration
-
Davit BM, Nwakama PE, Buehler GJ, et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother 2009;43:1583-1597.
-
(2009)
Ann Pharmacother
, vol.43
, pp. 1583-1597
-
-
Davit, B.M.1
Nwakama, P.E.2
Buehler, G.J.3
-
14
-
-
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
-
15
-
-
0036598634
-
Bioequivalence and the immunogenicity of biopharmaceuticals
-
Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002;1:457-462. (Pubitemid 37361488)
-
(2002)
Nature Reviews Drug Discovery
, vol.1
, Issue.6
, pp. 457-462
-
-
Schellekens, H.1
-
16
-
-
0034176711
-
Developments and improvements in the manufacturing of human therapeutics with mammalian cell cultures
-
DOI 10.1016/S0167-7799(99)01420-1, PII S0167779999014201
-
Hesse F, Wagner R. Developments and improvements in the manufacturing of human therapeutics with mammalian cell cultures. Trends Biotechnol 2000;18:173-180. (Pubitemid 30171336)
-
(2000)
Trends in Biotechnology
, vol.18
, Issue.4
, pp. 173-180
-
-
Hesse, F.1
Wagner, R.2
-
17
-
-
78649697382
-
Hearing shines spotlight on biosimilar controversies
-
Mullard A. Hearing shines spotlight on biosimilar controversies. Nat Rev Drug Discov 2010;9:905-906.
-
(2010)
Nat Rev Drug Discov
, vol.9
, pp. 905-906
-
-
Mullard, A.1
-
18
-
-
19044392727
-
The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes
-
DOI 10.1111/j.1523-1755.2005.00340.x
-
Boven K, Stryker S, Knight J, et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 2005;67:2346-2353. (Pubitemid 41623396)
-
(2005)
Kidney International
, vol.67
, Issue.6
, pp. 2346-2353
-
-
Boven, K.1
Stryker, S.2
Knight, J.3
Thomas, A.4
Van Regenmortel, M.5
Kemeny, D.M.6
Power, D.7
Rossert, J.8
Casadevall, N.9
-
19
-
-
77957723026
-
Biosimilar epoetins and other "follow-on" biologics: Update on the European experiences
-
Jelkmann W. Biosimilar epoetins and other "follow-on" biologics: update on the European experiences. Am J Hematol 2010;85:771-780.
-
(2010)
Am J Hematol
, vol.85
, pp. 771-780
-
-
Jelkmann, W.1
-
26
-
-
0008348082
-
-
Available at: http://www.ema.europa.eu/ema/index.jsp?curl=/pages/ medicines/landing/epar-search.jsp&murl=menus/medicines/medicines. jsp&mid=WC0b01ac058001d125&searchTab=&alreadyLoaded=true&status= Authorised&status=Withdrawn&status=Suspended&status= Refused&keyword=Enter+keywords&searchType=name&taxonomyPath= Diseases&treeNumber=¤tCategory=Cancer&searchGenericType= generics. Accessed February 10, 2011
-
European Medicines Agency. European public assements reports: cancer. 2011. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=/pages/ medicines/landing/epar-search.jsp&murl=menus/medicines/medicines. jsp&mid=WC0b01ac058001d125&searchTab=&alreadyLoaded=true&status= Authorised&status=Withdrawn&status=Suspended&status= Refused&keyword=Enter+keywords&searchType=name&taxonomyPath= Diseases&treeNumber=¤tCategory=Cancer&searchGenericType= generics. Accessed February 10, 2011.
-
(2011)
European Public Assements Reports: Cancer
-
-
-
27
-
-
77950360464
-
European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UK
-
Reichert JM, Beck A, Iyer H. European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UK. MAbs 2009;1:394-416.
-
(2009)
MAbs
, vol.1
, pp. 394-416
-
-
Reichert, J.M.1
Beck, A.2
Iyer, H.3
-
30
-
-
44449151539
-
Follow-on biologics: Data exclusivity and the balance between innovation and competition
-
DOI 10.1038/nrd2532, PII NRD2532
-
Grabowski H. Follow-on biologics: data exclusivity and the balance between innovation and competition. Nat Rev Drug Discov 2008;7:479-488. (Pubitemid 351767116)
-
(2008)
Nature Reviews Drug Discovery
, vol.7
, Issue.6
, pp. 479-488
-
-
Grabowski, H.1
-
31
-
-
70449440279
-
WHO guidelines presage US biosimilars legislation?
-
Hodgson J. WHO guidelines presage US biosimilars legislation? Nat Biotechnol 2009;27:963-965.
-
(2009)
Nat Biotechnol
, vol.27
, pp. 963-965
-
-
Hodgson, J.1
-
33
-
-
75149112660
-
Strategies for entering the biosimilar market
-
Oldham T, ed. London, England: Biopharm Knowledge Publishing
-
Oldham T. Strategies for entering the biosimilar market. In: Oldham T, ed. Biosimilars-Evolution or Revolution. London, England: Biopharm Knowledge Publishing; 2006.
-
(2006)
Biosimilars-Evolution or Revolution
-
-
Oldham, T.1
-
34
-
-
78149269335
-
'Biosimilar' drugs poised to penetrate market
-
Ledford H. 'Biosimilar' drugs poised to penetrate market. Nature 2010;468:18-19.
-
(2010)
Nature
, vol.468
, pp. 18-19
-
-
Ledford, H.1
-
36
-
-
79958722014
-
Lenograstim reduces the incidence of febrile episodes, when compared with filgrastim, in multiple myeloma patients undergoing stem cell mobilization
-
Orciuolo E, Buda G, Marturano E, et al. Lenograstim reduces the incidence of febrile episodes, when compared with filgrastim, in multiple myeloma patients undergoing stem cell mobilization. Leuk Res 2011;35:899-903.
-
(2011)
Leuk Res
, vol.35
, pp. 899-903
-
-
Orciuolo, E.1
Buda, G.2
Marturano, E.3
-
37
-
-
0345276665
-
Comparison of lenograstim and filgrastim on haematological effects after autologous peripheral blood stem cell transplantation with high-dose chemotherapy
-
DOI 10.1185/030079903125002531
-
Kim IH, Park SK, Suh OK, Oh JM. Comparison of lenograstim and filgrastim on haematological effects after autologous peripheral blood stem cell transplantation with high-dose chemotherapy. Curr Med Res Opin 2003;19:753-759. (Pubitemid 37466146)
-
(2003)
Current Medical Research and Opinion
, vol.19
, Issue.8
, pp. 753-759
-
-
Kim, I.H.1
Park, S.K.2
Suh, O.-K.3
Oh, J.M.4
-
38
-
-
0030844875
-
Crossover study of the haematological effects and pharmacokinetics of glycosylated and non-glycosylated G-CSF in healthy volunteers
-
Watts MJ, Addison I, Long SG, et al. Crossover study of the haematological effects and pharmacokinetics of glycosylated and non-glycosylated G-CSF in healthy volunteers. Br J Haematol 1997;98:474-479. (Pubitemid 27345130)
-
(1997)
British Journal of Haematology
, vol.98
, Issue.2
, pp. 474-479
-
-
Watts, M.J.1
Addison, I.2
Long, S.G.3
Hartley, S.4
Warrington, S.5
Boyce, M.6
Linch, D.C.7
-
39
-
-
36048990829
-
Comparison of pegfilgrastim with filgrastim on febrile neutropenia, grade IV neutropenia and bone pain: A meta-analysis of randomized controlled trials
-
DOI 10.1185/030079907X219599
-
Pinto L, Liu Z, Doan Q, et al. Comparison of pegfilgrastim with filgrastim on febrile neutropenia, grade IV neutropenia and bone pain: a meta-analysis of randomized controlled trials. Curr Med Res Opin 2007;23:2283-2295. (Pubitemid 350246613)
-
(2007)
Current Medical Research and Opinion
, vol.23
, Issue.9
, pp. 2283-2295
-
-
Pinto, L.1
Liu, Z.2
Doan, Q.3
Bernal, M.4
Dubois, R.5
Lyman, G.6
-
40
-
-
66949127931
-
Cost-effectiveness of pegfilgrastim versus filgrastim primary prophylaxis in women with early-stage breast cancer receiving chemotherapy in the United States
-
Lyman GH, Lalla A, Barron RL, Dubois RW. Cost-effectiveness of pegfilgrastim versus filgrastim primary prophylaxis in women with early-stage breast cancer receiving chemotherapy in the United States. Clin Ther 2009;31:1092-1104.
-
(2009)
Clin Ther
, vol.31
, pp. 1092-1104
-
-
Lyman, G.H.1
Lalla, A.2
Barron, R.L.3
Dubois, R.W.4
-
41
-
-
77957844297
-
A phase III randomized equivalence study of biosimilar filgrastim versus Amgen filgrastim in patients receiving myelosuppressive chemotherapy for breast cancer
-
Waller CF, Semiglazov VF, Tjulandin S, et al. A phase III randomized equivalence study of biosimilar filgrastim versus Amgen filgrastim in patients receiving myelosuppressive chemotherapy for breast cancer. Onkologie 2010;33:504-511.
-
(2010)
Onkologie
, vol.33
, pp. 504-511
-
-
Waller, C.F.1
Semiglazov, V.F.2
Tjulandin, S.3
-
42
-
-
77955660522
-
Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: Results from a randomized, phase I trial
-
Waller CF, Bronchud M, Mair S, Challand R. Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. Ann Hematol 2010;89:927-933.
-
(2010)
Ann Hematol
, vol.89
, pp. 927-933
-
-
Waller, C.F.1
Bronchud, M.2
Mair, S.3
Challand, R.4
-
43
-
-
77956671914
-
Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: Results from a randomized, phase I trial
-
Waller CF, Bronchud M, Mair S, Challand R. Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. Ann Hematol 2010;89:971-978.
-
(2010)
Ann Hematol
, vol.89
, pp. 971-978
-
-
Waller, C.F.1
Bronchud, M.2
Mair, S.3
Challand, R.4
-
44
-
-
77956228089
-
Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim
-
Skrlin A, Radic I, Vuletic M, et al. Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim. Biologicals 2010;38:557-566.
-
(2010)
Biologicals
, vol.38
, pp. 557-566
-
-
Skrlin, A.1
Radic, I.2
Vuletic, M.3
-
45
-
-
67349221747
-
Assessing the bioequivalence of biosimilars the Retacrit case
-
Schellekens H. Assessing the bioequivalence of biosimilars the Retacrit case. Drug Discov Today 2009;14:495-499.
-
(2009)
Drug Discov Today
, vol.14
, pp. 495-499
-
-
Schellekens, H.1
-
46
-
-
58149163304
-
Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: Issues and opportunities
-
DiMartino LD, Curtis LH, Williams RL, et al. Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities. Food Drug Law J 2008;63:891-900.
-
(2008)
Food Drug Law J
, vol.63
, pp. 891-900
-
-
DiMartino, L.D.1
Curtis, L.H.2
Williams, R.L.3
|