-
3
-
-
84873635799
-
The role of biosimilars in the treatment of rheumatic diseases
-
Dorner T, Strand V, Castaneda-Hernandez G, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013;72:322-8.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 322-328
-
-
Dorner, T.1
Strand, V.2
Castaneda-Hernandez, G.3
-
4
-
-
84878080621
-
Biosimilars: Part 1: Proposed regulatory criteria for FDA approval
-
Ventola CL. Biosimilars: Part 1: proposed regulatory criteria for FDA approval. P&T 2013;38:270-87.
-
(2013)
P&T
, vol.38
, pp. 270-287
-
-
Ventola, C.L.1
-
5
-
-
79961116944
-
Developing the nation's biosimilars program
-
Kozlowski S, Woodcock J, Midthun K, et al. Developing the nation's biosimilars program. N Engl J Med 2011;365:385-8.
-
(2011)
N Engl J Med
, vol.365
, pp. 385-388
-
-
Kozlowski, S.1
Woodcock, J.2
Midthun, K.3
-
9
-
-
33644952525
-
-
European Medicines Agency London, UK; Report No.: CHMP/437/04 rev 1
-
European Medicines Agency. Guideline on similar biological medicinal products. London, UK; 2014. Report No.: CHMP/437/04 rev 1.
-
(2014)
Guideline on Similar Biological Medicinal Products
-
-
-
11
-
-
84979713298
-
Assessing analytical similarity of proposed amgen biosimilar ABP 501 to adalimumab
-
Liu J, Eris T, Li C, et al. Assessing analytical similarity of proposed amgen biosimilar ABP 501 to adalimumab. BioDrugs 2016; doi:10.1007/s40259-016-0184-3
-
(2016)
BioDrugs
-
-
Liu, J.1
Eris, T.2
Li, C.3
-
12
-
-
84978924417
-
Demonstration of functional similarity of proposed biosimilar ABP 501 to adalimumab
-
Velayudhan J, Chen Y-f, Rohrbach A, et al. Demonstration of functional similarity of proposed biosimilar ABP 501 to adalimumab. BioDrugs 2016; doi:10.1007/ s40259-016-0185-2
-
(2016)
BioDrugs
-
-
Velayudhan, J.1
Y-F, C.2
Rohrbach, A.3
-
13
-
-
85014705217
-
Relationship between pharmacokinetics and antidrug antibody status of ABP 501, a biosimilar candidate to adalimumab
-
Dublin, Ireland. April 22-26
-
Kaur P, Chow VZ, N, MoxnessM, et al. Relationship between pharmacokinetics and antidrug antibody status of ABP 501, a biosimilar candidate to adalimumab. European League Against Rheumatism Annual European Conference April 22-26, 2015; Dublin, Ireland.
-
(2015)
European League Against Rheumatism Annual European Conference
-
-
Kaur, P.1
Chow, V.Z.N.2
Moxness, M.3
-
15
-
-
25444453709
-
Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies
-
Moxness M, Tatarewicz S, Weeraratne D, et al. Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies. Clin Chem 2005;51:1983-5.
-
(2005)
Clin Chem
, vol.51
, pp. 1983-1985
-
-
Moxness, M.1
Tatarewicz, S.2
Weeraratne, D.3
-
16
-
-
58249116651
-
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
-
Shankar G, Devanarayan V, Amaravadi L, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal 2008;48:1267-81.
-
(2008)
J Pharm Biomed Anal
, vol.48
, pp. 1267-1281
-
-
Shankar, G.1
Devanarayan, V.2
Amaravadi, L.3
-
18
-
-
67649932264
-
-
London, UK European Medicines Agency
-
European Medicines Agency. Guideline on the investigation of bioequivalence. London, UK 2010. http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2010/01/WC500070039.pdf
-
(2010)
Guideline on the Investigation of Bioequivalence
-
-
-
19
-
-
46549084098
-
Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: The CHANGE study
-
Miyasaka N. Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE study. Mod Rheumatol 2008;18:252-62.
-
(2008)
Mod Rheumatol
, vol.18
, pp. 252-262
-
-
Miyasaka, N.1
-
20
-
-
10744227300
-
Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: A 12 week, phase II study
-
van de Putte LB, Rau R, Breedveld FC, et al. Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study. Ann Rheum Dis 2003;62:1168-77.
-
(2003)
Ann Rheum Dis
, vol.62
, pp. 1168-1177
-
-
Van De Putte, L.B.1
Rau, R.2
Breedveld, F.C.3
-
21
-
-
47349125355
-
An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: Relationship to reasons for failure and anti-infliximab antibody status
-
van der Bijl AE, Breedveld FC, Antoni CE, et al. An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and anti-infliximab antibody status. Clin Rheumatol 2008;27:1021-8.
-
(2008)
Clin Rheumatol
, vol.27
, pp. 1021-1028
-
-
Van Der Bijl, A.E.1
Breedveld, F.C.2
Antoni, C.E.3
-
22
-
-
70349504171
-
Erosive progression is minimal, but erosion healing rare, in patients with rheumatoid arthritis treated with adalimumab. A 1 year investigator-initiated follow-up study using high-resolution computed tomography as the primary outcome measure
-
Moller Dohn U, Boonen A, Hetland ML, et al. Erosive progression is minimal, but erosion healing rare, in patients with rheumatoid arthritis treated with adalimumab. A 1 year investigator-initiated follow-up study using high-resolution computed tomography as the primary outcome measure. Ann Rheum Dis 2009;68:1585-90.
-
(2009)
Ann Rheum Dis
, vol.68
, pp. 1585-1590
-
-
Moller Dohn, U.1
Boonen, A.2
Hetland, M.L.3
-
24
-
-
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;72:1605-12.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1605-1612
-
-
Park, W.1
Hrycaj, P.2
Jeka, S.3
-
25
-
-
84874518073
-
Monitoring of adalimumab and antibodies-to-adalimumab levels in patient serum by the homogeneous mobility shift assay
-
Wang SL, Hauenstein S, Ohrmund L, et al. Monitoring of adalimumab and antibodies-to-adalimumab levels in patient serum by the homogeneous mobility shift assay. J Pharm Biomed Anal 2013;78-79:39-44.
-
(2013)
J Pharm Biomed Anal
, vol.78-79
, pp. 39-44
-
-
Wang, S.L.1
Hauenstein, S.2
Ohrmund, L.3
-
26
-
-
76749092658
-
Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis
-
Lecluse LL, Driessen RJ, Spuls PI, et al. Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol 2010;146:127-32.
-
(2010)
Arch Dermatol
, vol.146
, pp. 127-132
-
-
Lecluse, L.L.1
Driessen, R.J.2
Spuls, P.I.3
-
27
-
-
34347267600
-
Clinical response to adalimumab: Relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis
-
Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 2007;66:921-6.
-
(2007)
Ann Rheum Dis
, vol.66
, pp. 921-926
-
-
Bartelds, G.M.1
Wijbrandts, C.A.2
Nurmohamed, M.T.3
-
28
-
-
79953906254
-
Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up
-
Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011;305:1460-8.
-
(2011)
JAMA
, vol.305
, pp. 1460-1468
-
-
Bartelds, G.M.1
Krieckaert, C.L.2
Nurmohamed, M.T.3
-
29
-
-
70449725246
-
Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis
-
Radstake TR, Svenson M, Eijsbouts AM, et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 2009;68:1739-45.
-
(2009)
Ann Rheum Dis
, vol.68
, pp. 1739-1745
-
-
Radstake, T.R.1
Svenson, M.2
Eijsbouts, A.M.3
-
30
-
-
84872060066
-
Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: A real issue, a clinical perspective
-
Vincent FB, Morand EF, Murphy K, et al. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis 2013;72:165-78.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 165-178
-
-
Vincent, F.B.1
Morand, E.F.2
Murphy, K.3
|