-
1
-
-
84960851952
-
The changing landscape of biosimilars in rheumatology
-
Dörner T, Strand V, Cornes P, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis 2016;75:974-82.
-
(2016)
Ann Rheum Dis
, vol.75
, pp. 974-982
-
-
Dörner, T.1
Strand, V.2
Cornes, P.3
-
2
-
-
84893721202
-
Efficacy of biological disease-modifying antirheumatic drugs: A systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis
-
Nam JL, Ramiro S, Gaujoux-Viala C, et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2014;73:516-28.
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 516-528
-
-
Nam, J.L.1
Ramiro, S.2
Gaujoux-Viala, C.3
-
3
-
-
84882516214
-
Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country's wealth?
-
Putrik P, Ramiro S, Kvien TK, et al. Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country's wealth? Ann Rheum Dis 2014;73:2010-21.
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 2010-2021
-
-
Putrik, P.1
Ramiro, S.2
Kvien, T.K.3
-
4
-
-
84889688016
-
Inequities in access to biologic and synthetic DMARDs across 46 European countries
-
Putrik P, Ramiro S, Kvien TK, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis 2014;73:198-206.
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 198-206
-
-
Putrik, P.1
Ramiro, S.2
Kvien, T.K.3
-
8
-
-
84941584714
-
A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy
-
Choe JY, Prodanovic N, Niebrzydowski J, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2017;76:58-64.
-
(2017)
Ann Rheum Dis
, vol.76
, pp. 58-64
-
-
Choe, J.Y.1
Prodanovic, N.2
Niebrzydowski, J.3
-
9
-
-
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;76:51-7.
-
(2017)
Ann Rheum Dis
, vol.76
, pp. 51-57
-
-
Emery, P.1
Vencovský, J.2
Sylwestrzak, A.3
-
10
-
-
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;72:1613-20.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1613-1620
-
-
Yoo, D.H.1
Hrycaj, P.2
Miranda, P.3
-
11
-
-
84964570093
-
Editorial: Biosimilars: New or deja vu?
-
Kay J. Editorial: biosimilars: new or deja vu? Arthritis Rheumatol 2016;68:1049-52.
-
(2016)
Arthritis Rheumatol
, vol.68
, pp. 1049-1052
-
-
Kay, J.1
-
12
-
-
77952118055
-
-
Janssen Biologics B.V. accessed 28 Feb 2017
-
Janssen Biologics B.V. Summary of product characteristics: Remicade. http://www. ema. europa. eu/ docs/ en-GB/ document-library/ EPAR-Product-Information/ human/ 000240/ WC500050888. pdf (accessed 28 Feb 2017).
-
Summary of Product Characteristics: Remicade
-
-
-
13
-
-
84951020928
-
A randomized, phase I pharmacokinetic study comparing SB2 and Infliximab reference product (Remicade(®)) in healthy subjects
-
Shin D, Kim Y, Kim YS, et al. A randomized, phase I pharmacokinetic study comparing SB2 and Infliximab reference product (Remicade(®)) in healthy subjects. BioDrugs 2015;29:381-8.
-
(2015)
BioDrugs
, vol.29
, pp. 381-388
-
-
Shin, D.1
Kim, Y.2
Kim, Y.S.3
-
14
-
-
85009739531
-
Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab)
-
Hong J, Lee Y, Lee C, et al. Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab). MAbs 2017;9:365-83.
-
(2017)
MAbs
, vol.9
, pp. 365-383
-
-
Hong, J.1
Lee, Y.2
Lee, C.3
-
15
-
-
85041505597
-
Summary of opinion (initial authorisation)
-
European Medicines Agency accessed 12 Apr 2017
-
European Medicines Agency. Summary of opinion (initial authorisation). Flixabi. Infliximab. http://www. ema. europa. eu/ docs/ en-GB/ document-library/ Summary-of-opinion-Initial-authorisation/ human/ 004020/ WC500203991. pdf (accessed 12 Apr 2017).
-
Flixabi. Infliximab
-
-
-
16
-
-
85041493462
-
-
accessed 12 Apr 2017
-
Samsung Bioepis. Samsung Bioepis' Biologics License Application for SB2 infliximabb: Newsroom. http://www. samsungbioepis. com/ en/ newsroom/ detail/ Samsung-Bioepis-Biologics-License-Application-for-SB2-Infliximab-Biosimilar-Accepted-by-FDA. html (accessed 12 Apr 2017).
-
Samsung Bioepis' Biologics License Application for SB2 Infliximabb: Newsroom
-
-
-
17
-
-
85029779740
-
Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: Clinical, structural and safety results
-
Smolen JS, Choe JY, Prodanovic N, et al. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results. Rheumatology 2017;56:1771-1779.
-
(2017)
Rheumatology
, vol.56
, pp. 1771-1779
-
-
Smolen, J.S.1
Choe, J.Y.2
Prodanovic, N.3
-
18
-
-
84859853303
-
Rheumatoid arthritis disease activity measures: American college of rheumatology recommendations for use in clinical practice
-
Anderson J, Caplan L, Yazdany J, et al. Rheumatoid arthritis disease activity measures: american college of rheumatology recommendations for use in clinical practice. Arthritis Care Res 2012;64:640-7.
-
(2012)
Arthritis Care Res
, vol.64
, pp. 640-647
-
-
Anderson, J.1
Caplan, L.2
Yazdany, J.3
-
19
-
-
85019086175
-
Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): A 52-week, randomised, double-blind, non-inferiority trial
-
Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017;389:2304-16.
-
(2017)
Lancet
, vol.389
, pp. 2304-2316
-
-
Jørgensen, K.K.1
Olsen, I.C.2
Goll, G.L.3
-
20
-
-
85020798557
-
A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry
-
Glintborg B, Sørensen IJ, Loft AG, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis 2017;76:1426-31.
-
(2017)
Ann Rheum Dis
, vol.76
, pp. 1426-1431
-
-
Glintborg, B.1
Sørensen, I.J.2
Loft, A.G.3
-
21
-
-
84966417145
-
Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: Comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study
-
Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2017;76:355-63.
-
(2017)
Ann Rheum Dis
, vol.76
, pp. 355-363
-
-
Yoo, D.H.1
Prodanovic, N.2
Jaworski, J.3
-
22
-
-
85038082940
-
Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4
-
Emery P, Vencovský J, Sylwestrzak A, et al. Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4. Ann Rheum Dis 2017;76:1986-91.
-
(2017)
Ann Rheum Dis
, vol.76
, pp. 1986-1991
-
-
Emery, P.1
Vencovský, J.2
Sylwestrzak, A.3
-
23
-
-
85014009195
-
The EGALITY study: A confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. The originator product in patients with moderate-to-severe chronic plaque-type psoriasis
-
Griffiths CEM, Thaçi D, Gerdes S, et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2017;176:928-38.
-
(2017)
Br J Dermatol
, vol.176
, pp. 928-938
-
-
Griffiths, C.E.M.1
Thaçi, D.2
Gerdes, S.3
-
24
-
-
77955406512
-
The nocebo effect: A reason for patients' nonadherence to generic substitution?
-
Weissenfeld J, Stock S, Lüngen M, et al. The nocebo effect: a reason for patients' nonadherence to generic substitution? Pharmazie 2010;65:451-6.
-
(2010)
Pharmazie
, vol.65
, pp. 451-456
-
-
Weissenfeld, J.1
Stock, S.2
Lüngen, M.3
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