-
1
-
-
33749860977
-
Post-translational modifications in the context of therapeutic proteins
-
Walsh G, Jefferis R. Post-translational modifications in the context of therapeutic proteins. Nat Biotechnol. 2006;24:1241-1252.
-
(2006)
Nat Biotechnol
, vol.24
, pp. 1241-1252
-
-
Walsh, G.1
Jefferis, R.2
-
2
-
-
71549136813
-
Identification and quantification of protein posttranslational modifications
-
Farley AR, Link AJ. Identification and quantification of protein posttranslational modifications. Methods Enzymol. 2009;463:725-763.
-
(2009)
Methods Enzymol
, vol.463
, pp. 725-763
-
-
Farley, A.R.1
Link, A.J.2
-
3
-
-
0141922918
-
Shifting paradigms: Biopharmaceuticals versus low molecular weight drugs
-
Crommelin DJ, Storm G, Verrijk R, et al. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm. 2003;266:3-16.
-
(2003)
Int J Pharm
, vol.266
, pp. 3-16
-
-
Crommelin, D.J.1
Storm, G.2
Verrijk, R.3
-
4
-
-
85010411109
-
Pharmacokinetic modeling and simulation of biologicals in inflammatory bowel disease: The dawning of a new era for personalized treatment
-
In press
-
Dreesen E, Gils A, Vermeire S. Pharmacokinetic modeling and simulation of biologicals in inflammatory bowel disease: the dawning of a new era for personalized treatment. Curr Drug Targets. 2016. In press.
-
(2016)
Curr Drug Targets
-
-
Dreesen, E.1
Gils, A.2
Vermeire, S.3
-
5
-
-
75149132833
-
Immunological mechanism underlying the immune response to recombinant human protein therapeutics
-
Sauerborn M, Brinks V, Jiskoot W, et al. Immunological mechanism underlying the immune response to recombinant human protein therapeutics. Trends Pharmacol Sci. 2010;31:53-59.
-
(2010)
Trends Pharmacol Sci
, vol.31
, pp. 53-59
-
-
Sauerborn, M.1
Brinks, V.2
Jiskoot, W.3
-
6
-
-
0016756272
-
Continuous cultures of fused cells secreting antibody of predefined specificity
-
Köhler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature. 1975;256:495-497.
-
(1975)
Nature
, vol.256
, pp. 495-497
-
-
Köhler, G.1
Milstein, C.2
-
8
-
-
84964523414
-
Antibodies to watch in 2016
-
Reichert JM. Antibodies to watch in 2016. MAbs. 2016;8:197-204.
-
(2016)
MAbs
, vol.8
, pp. 197-204
-
-
Reichert, J.M.1
-
9
-
-
84957991319
-
N-glycosylation heterogeneity and the influence on structure, function and pharmacokinetics of monoclonal antibodies and Fc fusion proteins
-
Higel F, Seidl A, Sörgel F, et al. N-glycosylation heterogeneity and the influence on structure, function and pharmacokinetics of monoclonal antibodies and Fc fusion proteins. Eur J Pharm Biopharm. 2016;100:94-100.
-
(2016)
Eur J Pharm Biopharm
, vol.100
, pp. 94-100
-
-
Higel, F.1
Seidl, A.2
Sörgel, F.3
-
10
-
-
0031775443
-
The complete nucleotide sequence of the human immunoglobulin heavy chain variable region locus
-
Matsuda F, Ishii K, Bourvagnet P, et al. The complete nucleotide sequence of the human immunoglobulin heavy chain variable region locus. J Exp Med. 1998;188:2151-2162.
-
(1998)
J Exp Med
, vol.188
, pp. 2151-2162
-
-
Matsuda, F.1
Ishii, K.2
Bourvagnet, P.3
-
11
-
-
84964576037
-
Evolution of costs of inflammatory bowel disease over two years of follow-up
-
van der Valk ME, Mangen MJ, Severs M, et al. Evolution of costs of inflammatory bowel disease over two years of follow-up. PLoS One. 2016;11:e0142481.
-
(2016)
PLoS One
, vol.11
, pp. e0142481
-
-
Van Der Valk, M.E.1
Mangen, M.J.2
Severs, M.3
-
12
-
-
85025625913
-
Current practice for therapeutic drug monitoring of biopharmaceuticals in rheumatoid arthritis
-
Medina F, Plasencia C, Goupille P, et al. Current practice for therapeutic drug monitoring of biopharmaceuticals in rheumatoid arthritis. Ther Drug Monit. 2017;39:364-369.
-
(2017)
Ther Drug Monit
, vol.39
, pp. 364-369
-
-
Medina, F.1
Plasencia, C.2
Goupille, P.3
-
13
-
-
85017168393
-
Current practice for therapeutic drug monitoring of biopharmaceuticals in spondyloarthritis
-
Medina F, Placensia C, Goupille P, et al. Current practice for therapeutic drug monitoring of biopharmaceuticals in spondyloarthritis. Ther Drug Monit. 2017;39:360-363.
-
(2017)
Ther Drug Monit
, vol.39
, pp. 360-363
-
-
Medina, F.1
Placensia, C.2
Goupille, P.3
-
14
-
-
85015949319
-
Drug Efficacy monitoring in pharmacotherapy of multiple sclerosis with biological agents
-
Caldano M, Raoul W, Rispens T, et al. Drug Efficacy monitoring in pharmacotherapy of multiple sclerosis with biological agents. Ther Drug Monit. 2017;39:350-355.
-
(2017)
Ther Drug Monit
, vol.39
, pp. 350-355
-
-
Caldano, M.1
Raoul, W.2
Rispens, T.3
-
15
-
-
85015932886
-
Current practice for therapeutic drug monitoring of biopharmaceuticals in inflammatory bowel disease
-
Detrez I, Van Stappen T, Arranz MD, et al. Current practice for therapeutic drug monitoring of biopharmaceuticals in inflammatory bowel disease. Ther Drug Monit. 2017;39:344-349.
-
(2017)
Ther Drug Monit
, vol.39
, pp. 344-349
-
-
Detrez, I.1
Van Stappen, T.2
Arranz, M.D.3
-
16
-
-
85017149779
-
Current practice of therapeutic drug monitoring of biopharmaceuticals in psoriasis patients
-
Hermans C, Harrans P, Segaert S, et al. Current practice of therapeutic drug monitoring of biopharmaceuticals in psoriasis patients. Ther Drug Monit. 2017;39:356-359.
-
(2017)
Ther Drug Monit
, vol.39
, pp. 356-359
-
-
Hermans, C.1
Harrans, P.2
Segaert, S.3
-
17
-
-
84857074714
-
Optimal use and cost-effectiveness of biologic therapies in inflammatory bowel disease
-
Di Sabatino A, Liberato L, Marchetti M, et al. Optimal use and cost-effectiveness of biologic therapies in inflammatory bowel disease. Intern Emerg Med. 2011;6(suppl 1):17-27.
-
(2011)
Intern Emerg Med
, vol.6
, pp. 17-27
-
-
Di Sabatino, A.1
Liberato, L.2
Marchetti, M.3
-
18
-
-
85011685257
-
Combining therapeutic drug monitoring with biosimilars, a strategy to improve efficacy of biologicals for treatment of IBD at an affordable cost
-
Gils A. Combining therapeutic drug monitoring with biosimilars, a strategy to improve efficacy of biologicals for treatment of IBD at an affordable cost. Dig Dis. 2017;35:61-68.
-
(2017)
Dig Dis
, vol.35
, pp. 61-68
-
-
Gils, A.1
-
19
-
-
67649932264
-
-
London, United Kingdom: European Medicines Agency, Accessed November 3, 2016
-
Guideline on the Investigation of Bioequivalence. London, United Kingdom: European Medicines Agency; 2010. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2010/01/WC500070039.pdf. Accessed November 3, 2016.
-
(2010)
Guideline on the Investigation of Bioequivalence
-
-
-
20
-
-
84872175228
-
Biosimilar monoclonal antibodies: A science-based regulatory challenge
-
Declerck PJ. Biosimilar monoclonal antibodies: a science-based regulatory challenge. Expert Opin Biol Ther. 2013;13:153-156.
-
(2013)
Expert Opin Biol Ther
, vol.13
, pp. 153-156
-
-
Declerck, P.J.1
-
21
-
-
84966283006
-
-
Accessed July 19, 2016
-
Guideline on Similar Biological Medicinal Products. 2014. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2014/10/WC500176768.pdf. Accessed July 19, 2016.
-
(2014)
Guideline on Similar Biological Medicinal Products
-
-
-
22
-
-
84898023506
-
Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures?
-
Farfan-Portet MI, Gerkens S, Lepage-Nefkens I, et al. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? Eur J Health Econ. 2014;15:223-228.
-
(2014)
Eur J Health Econ
, vol.15
, pp. 223-228
-
-
Farfan-Portet, M.I.1
Gerkens, S.2
Lepage-Nefkens, I.3
-
23
-
-
84921352030
-
The therapeutic monoclonal antibody market
-
Ecker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. MAbs. 2015;7:9-14.
-
(2015)
MAbs
, vol.7
, pp. 9-14
-
-
Ecker, D.M.1
Jones, S.D.2
Levine, H.L.3
-
24
-
-
84977641135
-
Overcoming barriers to the market access of biosimilars in the European Union the case of biosimilar monoclonal antibodies
-
Moorkens E, Jonker-Exler C, Huys I, et al. Overcoming barriers to the market access of biosimilars in the European Union: the case of biosimilar monoclonal antibodies. Front Pharmacol. 2016;7:193.
-
(2016)
Front Pharmacol
, vol.7
, pp. 193
-
-
Moorkens, E.1
Jonker-Exler, C.2
Huys, I.3
-
25
-
-
84960484742
-
-
Accessed November 3, 2016
-
Nonproprietary Naming of Biological Products 2015. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987.pdf. Accessed November 3, 2016.
-
(2015)
Nonproprietary Naming of Biological Products
-
-
-
26
-
-
84883746909
-
A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: The PLANETAS study
-
Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72: 1605-1612.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1605-1612
-
-
Park, W.1
Hrycaj, P.2
Jeka, S.3
-
27
-
-
84883752718
-
A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study
-
Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613-1620.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1613-1620
-
-
Yoo, D.H.1
Hrycaj, P.2
Miranda, P.3
-
28
-
-
84940081554
-
Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study
-
Jung YS, Park DI, Kim YH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015;3: 1705-1712.
-
(2015)
J Gastroenterol Hepatol
, vol.3
, pp. 1705-1712
-
-
Jung, Y.S.1
Park, D.I.2
Kim, Y.H.3
-
29
-
-
84942303588
-
Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study
-
Jahnsen J, Detlie TE, Vatn S, et al. Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: a Norwegian observational study. Expert Rev Gastroenterol Hepatol. 2015;9(suppl 1): 45-52.
-
(2015)
Expert Rev Gastroenterol Hepatol
, vol.9
, pp. 45-52
-
-
Jahnsen, J.1
Detlie, T.E.2
Vatn, S.3
-
30
-
-
85020318416
-
Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: A prospective, multicentre, nationwide cohort
-
Gecse KB, Lovász BD, Farkas K, et al. Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort. J Crohns Colitis. 2016;10: 133-140.
-
(2016)
J Crohns Colitis
, vol.10
, pp. 133-140
-
-
Gecse, K.B.1
Lovász, B.D.2
Farkas, K.3
-
32
-
-
85012255168
-
Clinical outcomes following a switch from Remicade® to the biosimilar CT-P13 in inflammatory bowel disease patients: A prospective observational cohort study
-
Smits LJ, Derikx LA, de Jong DJ, et al. Clinical outcomes following a switch from Remicade® to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. J Crohns Colitis. 2016;10:1287-1293.
-
(2016)
J Crohns Colitis
, vol.10
, pp. 1287-1293
-
-
Smits, L.J.1
Derikx, L.A.2
De Jong, D.J.3
-
33
-
-
84973896889
-
Cross-immunogenicity: Antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima
-
Ben-Horin S, Yavzori M, Benhar I, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2015;65:1132-1138.
-
(2015)
Gut
, vol.65
, pp. 1132-1138
-
-
Ben-Horin, S.1
Yavzori, M.2
Benhar, I.3
-
34
-
-
84962299660
-
Harmonization of infliximab and anti-infliximab assays facilitates the comparison between originators and biosimilars in clinical samples
-
Gils A, Van Stappen T, Dreesen E, et al. Harmonization of infliximab and anti-infliximab assays facilitates the comparison between originators and biosimilars in clinical samples. Inflamm Bowel Dis. 2016;22:969-975.
-
(2016)
Inflamm Bowel Dis
, vol.22
, pp. 969-975
-
-
Gils, A.1
Van Stappen, T.2
Dreesen, E.3
-
35
-
-
84937604672
-
A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
-
Emery P, Vencovský J, Sylwestrzak A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76:51-57.
-
(2017)
Ann Rheum Dis
, vol.76
, pp. 51-57
-
-
Emery, P.1
Vencovský, J.2
Sylwestrzak, A.3
-
36
-
-
84966318356
-
Response to "comparing the immunogenicity of the etanercept biosimilar SB4 with the innovator etanercept: Another consideration" by Marshall, et al
-
Emery P, Vencovský J, Ghil J, et al. Response to: "comparing the immunogenicity of the etanercept biosimilar SB4 with the innovator etanercept: another consideration" by Marshall, et al. Ann Rheum Dis. 2016;75:e38.
-
(2016)
Ann Rheum Dis
, vol.75
, pp. e38
-
-
Emery, P.1
Vencovský, J.2
Ghil, J.3
-
37
-
-
84963894569
-
Comparing the immunogenicity of the etanercept biosimilar SB4 with the innovator etanercept: Another consideration
-
Marshall L, Hickling T, Bill D, et al. Comparing the immunogenicity of the etanercept biosimilar SB4 with the innovator etanercept: another consideration. Ann Rheum Dis. 2016;75:e37.
-
(2016)
Ann Rheum Dis
, vol.75
, pp. e37
-
-
Marshall, L.1
Hickling, T.2
Bill, D.3
-
38
-
-
84970027799
-
Confirmation on the immunogenicity assay used in the SB4 phase III study: Response to the comments by Meacci et al
-
Emery P, Vencovský J, Kang JW, et al. Confirmation on the immunogenicity assay used in the SB4 phase III study: response to the comments by Meacci, et al. Ann Rheum Dis. 2016;75:e40.
-
(2016)
Ann Rheum Dis
, vol.75
, pp. e40
-
-
Emery, P.1
Vencovský, J.2
Kang, J.W.3
|