-
1
-
-
34247535331
-
Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution
-
Kuek A, Hazleman BL, Ostor AJ. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgrad Med J 2007; 83: 251-60.
-
(2007)
Postgrad Med J
, vol.83
, pp. 251-260
-
-
Kuek, A.1
Hazleman, B.L.2
Ostor, A.J.3
-
2
-
-
84892167981
-
Barriers to the prescription of systemic therapies for moderate-to-severe psoriasis: a multinational cross-sectional study
-
Nast A, Mrowietz U, Kragballe K et al. Barriers to the prescription of systemic therapies for moderate-to-severe psoriasis: a multinational cross-sectional study. Arch Dermatol Res 2013; 305: 899-907.
-
(2013)
Arch Dermatol Res
, vol.305
, pp. 899-907
-
-
Nast, A.1
Mrowietz, U.2
Kragballe, K.3
-
3
-
-
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
-
4
-
-
84949629891
-
-
Expert Committee on Biological Standardization. Geneva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs). (accessed 1 October 2014).
-
World Health Organization. Expert Committee on Biological Standardization. Geneva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs). Available at: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf (accessed 1 October 2014).
-
-
-
-
5
-
-
84888391581
-
Developing oncology biosimilars: an essential approach for the future
-
Abraham J. Developing oncology biosimilars: an essential approach for the future. Semin Oncol 2013; 40(Suppl. 1): S5-24.
-
(2013)
Semin Oncol
, vol.40
, pp. S5-24
-
-
Abraham, J.1
-
6
-
-
84923280531
-
Implementation and use of biosimilars in the therapy of inflammatory rheumatic diseases: statement of the German Society of Rheumatology
-
Lorenz HM, Braun J, Kruger K, Schneider M. Implementation and use of biosimilars in the therapy of inflammatory rheumatic diseases: statement of the German Society of Rheumatology. Z Rheumatol 2014; 73: 784-6.
-
(2014)
Z Rheumatol
, vol.73
, pp. 784-786
-
-
Lorenz, H.M.1
Braun, J.2
Kruger, K.3
Schneider, M.4
-
7
-
-
84884910025
-
Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases
-
Rinaudo-Gaujous M, Paul S, Tedesco ED, Genin C, Roblin X, Peyrin-Biroulet L. Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther 2013; 38: 914-24.
-
(2013)
Aliment Pharmacol Ther
, vol.38
, pp. 914-924
-
-
Rinaudo-Gaujous, M.1
Paul, S.2
Tedesco, E.D.3
Genin, C.4
Roblin, X.5
Peyrin-Biroulet, L.6
-
8
-
-
84904357521
-
The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis
-
Yoo DH. The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis. Expert Rev Clin Immunol 2014; 10: 981-3.
-
(2014)
Expert Rev Clin Immunol
, vol.10
, pp. 981-983
-
-
Yoo, D.H.1
-
9
-
-
84858760623
-
Biosimilar insulins: how similar is similar?
-
Heinemann L, Hompesch M. Biosimilar insulins: how similar is similar? J Diabetes Sci Technol 2011; 5: 741-54.
-
(2011)
J Diabetes Sci Technol
, vol.5
, pp. 741-754
-
-
Heinemann, L.1
Hompesch, M.2
-
10
-
-
84897377081
-
Biosimilars: in support of extrapolation of indications
-
Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis 2014; 8: 431-5.
-
(2014)
J Crohns Colitis
, vol.8
, pp. 431-435
-
-
Ebbers, H.C.1
-
11
-
-
84904069611
-
The challenge of indication extrapolation for infliximab biosimilars
-
Feagan BG, Choquette D, Ghosh S et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014; 42: 177-83.
-
(2014)
Biologicals
, vol.42
, pp. 177-183
-
-
Feagan, B.G.1
Choquette, D.2
Ghosh, S.3
-
12
-
-
84893044719
-
Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?
-
Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014; 16: 22-6.
-
(2014)
AAPS J
, vol.16
, pp. 22-26
-
-
Lee, H.1
-
13
-
-
84911401436
-
Biosimilars: the science of extrapolation
-
Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood 2014; 124: 3191-6.
-
(2014)
Blood
, vol.124
, pp. 3191-3196
-
-
Weise, M.1
Kurki, P.2
Wolff-Holz, E.3
Bielsky, M.C.4
Schneider, C.K.5
-
14
-
-
84905717145
-
Statistical and regulatory considerations in assessments of interchangeability of biological drug products
-
Tothfalusi L, Endrenyi L, Chow SC. Statistical and regulatory considerations in assessments of interchangeability of biological drug products. Eur J Health Econ 2014; 15(Suppl. 1): S5-11.
-
(2014)
Eur J Health Econ
, vol.15
, pp. S5-11
-
-
Tothfalusi, L.1
Endrenyi, L.2
Chow, S.C.3
-
15
-
-
84874169316
-
Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations
-
Chamberlain P. Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations. Bioanalysis 2013; 5: 561-74.
-
(2013)
Bioanalysis
, vol.5
, pp. 561-574
-
-
Chamberlain, P.1
-
16
-
-
84870933584
-
Interchangeability, immunogenicity and biosimilars
-
Ebbers HC, Crow SA, Vulto AG, Schellekens H. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 2012; 30: 1186-90.
-
(2012)
Nat Biotechnol
, vol.30
, pp. 1186-1190
-
-
Ebbers, H.C.1
Crow, S.A.2
Vulto, A.G.3
Schellekens, H.4
-
18
-
-
77955636779
-
Biosimilars: pharmacovigilance and risk management
-
Zuniga L, Calvo B. Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf 2010; 19: 661-9.
-
(2010)
Pharmacoepidemiol Drug Saf
, vol.19
, pp. 661-669
-
-
Zuniga, L.1
Calvo, B.2
-
19
-
-
33644952525
-
Guideline on Similar Biological Medicine Products
-
Draft. 22 May 2013. (accessed 20 October 2014).
-
European Medicines Agency. Guideline on Similar Biological Medicine Products. Draft. 22 May 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf (accessed 20 October 2014).
-
-
-
-
20
-
-
84949629892
-
-
Assessment report: Remsima (infliximab). 27 June 2013. (accessed 2 October 2014).
-
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment report: Remsima (infliximab). 27 June 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf (accessed 2 October 2014).
-
-
-
-
21
-
-
84949629893
-
-
Remsima (infliximab). Summary of Product Characteristics. (accessed 22 October 2014).
-
European Medicines Agency. Remsima (infliximab). Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf (accessed 22 October 2014).
-
-
-
-
22
-
-
84949629894
-
-
Remicade (infliximab). Summary of Product Characteristics. (accessed 22 October 2014
-
European Medicines Agency. Remicade (infliximab). Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000240/WC500050888.pdf (accessed 22 October 2014).
-
-
-
-
23
-
-
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
-
24
-
-
84913533583
-
Physicochemical characterization of Remsima®
-
Jung SK, Lee KH, Jeon JW et al. Physicochemical characterization of Remsima®. MAbs 2014; 6: 1163-77.
-
(2014)
MAbs
, vol.6
, pp. 1163-1177
-
-
Jung, S.K.1
Lee, K.H.2
Jeon, J.W.3
-
25
-
-
84894289194
-
ECCO position challenged by European drug regulators
-
Working Party on Similar Biological Medicinal Products of Committee for Medicinal Products for Human Use (CHMP)
-
Kurki P, Bielsky MC, Working Party on Similar Biological Medicinal Products of Committee for Medicinal Products for Human Use (CHMP). ECCO position challenged by European drug regulators. J Crohns Colitis 2014; 8: 258.
-
(2014)
J Crohns Colitis
, vol.8
, pp. 258
-
-
Kurki, P.1
Bielsky, M.C.2
-
26
-
-
77958520182
-
Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor alpha
-
Shealy DJ, Cai A, Staquet K et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor alpha. MAbs 2010; 2: 428-39.
-
(2010)
MAbs
, vol.2
, pp. 428-439
-
-
Shealy, D.J.1
Cai, A.2
Staquet, K.3
-
27
-
-
84942354506
-
A randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, and tolerability of three formulations of infliximab (CT-P13, EU-sourced infliximab and US-sourced infliximab) in healthy volunteers
-
1509
-
Yoo D-H, Park W, Shim S-C, Suh C-H, Yun J, Pyo T. A randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, and tolerability of three formulations of infliximab (CT-P13, EU-sourced infliximab and US-sourced infliximab) in healthy volunteers. Arthritis Rheumatol 2014; 11(Suppl.): S664. (1509).
-
(2014)
Arthritis Rheumatol
, vol.11
, pp. S664
-
-
Yoo, D.-H.1
Park, W.2
Shim, S.-C.3
Suh, C.-H.4
Yun, J.5
Pyo, T.6
-
28
-
-
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
-
29
-
-
84885386721
-
A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the PLANETAS study
-
FRI0421].
-
Park W, Jaworski J, Brzezicki J et al. A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the PLANETAS study. Ann Rheum Dis 2013; 72(Suppl. 3): 516. [FRI0421].
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 516
-
-
Park, W.1
Jaworski, J.2
Brzezicki, J.3
-
30
-
-
84885388564
-
A phase 3 randomised controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study
-
OP0068
-
Yoo DH, Racewicz A, Brzezicki J et al. A phase 3 randomised controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study. Ann Rheum Dis 2013; 72(Suppl. 3): 73. [OP0068].
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 73
-
-
Yoo, D.H.1
Racewicz, A.2
Brzezicki, J.3
-
31
-
-
77950988234
-
Infliximab, azathioprine, or combination therapy for Crohn's disease
-
Colombel JF, Sandborn WJ, Reinisch W et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010; 362: 1383-95.
-
(2010)
N Engl J Med
, vol.362
, pp. 1383-1395
-
-
Colombel, J.F.1
Sandborn, W.J.2
Reinisch, W.3
-
32
-
-
0033524159
-
Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group
-
Maini R, St Clair EW, Breedveld F et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999; 354: 1932-9.
-
(1999)
Lancet
, vol.354
, pp. 1932-1939
-
-
Maini, R.1
St Clair, E.W.2
Breedveld, F.3
-
33
-
-
33646379583
-
The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial
-
Westhovens R, Yocum D, Han J et al. The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial. Arthritis Rheum 2006; 54: 1075-86.
-
(2006)
Arthritis Rheum
, vol.54
, pp. 1075-1086
-
-
Westhovens, R.1
Yocum, D.2
Han, J.3
-
34
-
-
84949627156
-
Inhibition of radiographic progression and its Bath AS Disease Activity Index association with clinical parameters in RA patients treated with CT-P13 and innovator infliximab in PLANETRA study
-
THU0158
-
Yoo D, Park W, Miranda P et al. Inhibition of radiographic progression and its Bath AS Disease Activity Index association with clinical parameters in RA patients treated with CT-P13 and innovator infliximab in PLANETRA study. Ann Rheum Dis 2014; 73(Suppl. 2): 234-5. THU0158.
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 234-235
-
-
Yoo, D.1
Park, W.2
Miranda, P.3
-
35
-
-
84942273178
-
Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13
-
L1
-
Yoo DH, Prodanovic N, Jaworski J et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum 2013; 65: 3319. (L1).
-
(2013)
Arthritis Rheum
, vol.65
, pp. 3319
-
-
Yoo, D.H.1
Prodanovic, N.2
Jaworski, J.3
-
36
-
-
84949626596
-
Investigation of the pharmacokinetic equivalence, efficacy and safety of the biosimilar product, CT-P13, with its original drug, infliximab
-
W14-4
-
Takeuchi T, Yamanaka H, Tanaka Y, Sakurai T, Ohtsubo H, Nambu Y. Investigation of the pharmacokinetic equivalence, efficacy and safety of the biosimilar product, CT-P13, with its original drug, infliximab. Mod Rheumatol 2014; 24: S60. (W14-4).
-
(2014)
Mod Rheumatol
, vol.24
, pp. S60
-
-
Takeuchi, T.1
Yamanaka, H.2
Tanaka, Y.3
Sakurai, T.4
Ohtsubo, H.5
Nambu, Y.6
-
37
-
-
84942273177
-
Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13
-
L15
-
Park W, Miranda P, Brzosko M et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum 2013; 65: 3326. (L15).
-
(2013)
Arthritis Rheum
, vol.65
, pp. 3326
-
-
Park, W.1
Miranda, P.2
Brzosko, M.3
-
38
-
-
84934294253
-
Clinical experience of the use of CT-P13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series
-
Kang YS, Moon HH, Lee SE, Lim YJ, Kang HW. Clinical experience of the use of CT-P13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series. Dig Dis Sci 2014; 60: 951-6.
-
(2014)
Dig Dis Sci
, vol.60
, pp. 951-956
-
-
Kang, Y.S.1
Moon, H.H.2
Lee, S.E.3
Lim, Y.J.4
Kang, H.W.5
-
39
-
-
25444517037
-
C. BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-alpha treatment
-
British Thoracic Society Standards of Care
-
British Thoracic Society Standards of Care. C. BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-alpha treatment. Thorax 2005; 60: 800-5.
-
(2005)
Thorax
, vol.60
, pp. 800-805
-
-
-
40
-
-
84874656491
-
Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis
-
van Schouwenburg PA, Rispens T, Wolbink GJ. Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol 2013; 9: 164-72.
-
(2013)
Nat Rev Rheumatol
, vol.9
, pp. 164-172
-
-
van Schouwenburg, P.A.1
Rispens, T.2
Wolbink, G.J.3
-
41
-
-
85027197072
-
Disease activity assessment using the DAS28, CDAI and SDAI and effect of anti-drug antibody on clinical response in a randomized, double-blind, comparative trial of CT-P13 and innovator infliximab: PLANETRA study
-
THU0159].
-
Yoo DH, Park W, Brzosko M et al. Disease activity assessment using the DAS28, CDAI and SDAI and effect of anti-drug antibody on clinical response in a randomized, double-blind, comparative trial of CT-P13 and innovator infliximab: PLANETRA study. Ann Rheum Dis 2014; 73(Suppl. 2): 235. [THU0159].
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 235
-
-
Yoo, D.H.1
Park, W.2
Brzosko, M.3
-
42
-
-
84998791494
-
Clinical response of disease activity, disability and mobility indices in relation to anti-drug antibody in the PLANETAS study
-
OP0157
-
Park W, Woo DH, Szanto S et al. Clinical response of disease activity, disability and mobility indices in relation to anti-drug antibody in the PLANETAS study. Ann Rheum Dis 2014; 73(Suppl. 2): 121. [OP0157].
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 121
-
-
Park, W.1
Woo, D.H.2
Szanto, S.3
-
43
-
-
84949629895
-
-
European Medicines Agency. Guideline on Similar Biological Medicine Products Containing Monoclonal Antibodies - Non-clinical and Clinical Issues. Draft. 30 May 2012. (accessed 13 April 2015).
-
European Medicines Agency. Guideline on Similar Biological Medicine Products Containing Monoclonal Antibodies - Non-clinical and Clinical Issues. Draft. 30 May 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf (accessed 13 April 2015).
-
-
-
-
44
-
-
84900807640
-
The role of tumour necrosis factor in the pathogenesis of immune-mediated diseases
-
Blandizzi C, Gionchetti P, Armuzzi A et al. The role of tumour necrosis factor in the pathogenesis of immune-mediated diseases. Int J Immunopathol Pharmacol 2014; 27: 1-10.
-
(2014)
Int J Immunopathol Pharmacol
, vol.27
, pp. 1-10
-
-
Blandizzi, C.1
Gionchetti, P.2
Armuzzi, A.3
-
45
-
-
0034754477
-
Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial
-
Sandborn WJ, Hanauer SB, Katz S et al. Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology 2001; 121: 1088-94.
-
(2001)
Gastroenterology
, vol.121
, pp. 1088-1094
-
-
Sandborn, W.J.1
Hanauer, S.B.2
Katz, S.3
-
47
-
-
84901833561
-
Certolizumab for rheumatoid arthritis
-
Markatseli TE, Papagoras C, Nikoli A, Voulgari PV, Drosos AA. Certolizumab for rheumatoid arthritis. Clin Exp Rheumatol 2014; 32: 415-23.
-
(2014)
Clin Exp Rheumatol
, vol.32
, pp. 415-423
-
-
Markatseli, T.E.1
Papagoras, C.2
Nikoli, A.3
Voulgari, P.V.4
Drosos, A.A.5
-
48
-
-
84879206045
-
The cytotoxic effects of certolizumab pegol and golimumab mediated by transmembrane tumor necrosis factor alpha
-
Ueda N, Tsukamoto H, Mitoma H et al. The cytotoxic effects of certolizumab pegol and golimumab mediated by transmembrane tumor necrosis factor alpha. Inflamm Bowel Dis 2013; 19: 1224-31.
-
(2013)
Inflamm Bowel Dis
, vol.19
, pp. 1224-1231
-
-
Ueda, N.1
Tsukamoto, H.2
Mitoma, H.3
-
49
-
-
36749070996
-
Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents
-
Nesbitt A, Fossati G, Bergin M et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis 2007; 13: 1323-32.
-
(2007)
Inflamm Bowel Dis
, vol.13
, pp. 1323-1332
-
-
Nesbitt, A.1
Fossati, G.2
Bergin, M.3
-
50
-
-
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
-
51
-
-
84883746643
-
Biosimilars to treat inflammatory arthritis: the challenge of proving identity
-
Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis 2013; 72: 1589-93.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1589-1593
-
-
Kay, J.1
Smolen, J.S.2
-
52
-
-
84873679430
-
Biosimilars in rheumatology: the wind of change
-
Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013; 72: 315-8.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 315-318
-
-
Schneider, C.K.1
-
53
-
-
79953861167
-
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
-
Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011; 29: 310-2.
-
(2011)
Nat Biotechnol
, vol.29
, pp. 310-312
-
-
Schiestl, M.1
Stangler, T.2
Torella, C.3
Cepeljnik, T.4
Toll, H.5
Grau, R.6
-
54
-
-
84876938678
-
Biosimilars in IBD: hope or expectation?
-
Gecse KB, Khanna R, van den Brink GR et al. Biosimilars in IBD: hope or expectation? Gut 2013; 62: 803-7.
-
(2013)
Gut
, vol.62
, pp. 803-807
-
-
Gecse, K.B.1
Khanna, R.2
van den Brink, G.R.3
-
55
-
-
84902275395
-
The biosimilar road in inflammatory bowel disease: the right way?
-
Fiorino G, Danese S. The biosimilar road in inflammatory bowel disease: the right way? Best Pract Res Clin Gastroenterol 2014; 28: 465-71.
-
(2014)
Best Pract Res Clin Gastroenterol
, vol.28
, pp. 465-471
-
-
Fiorino, G.1
Danese, S.2
-
56
-
-
84949629896
-
-
European Commission. Consensus Information Paper 2013. What you need to know about biosimilar medicinal products. (accessed 5 October 2014).
-
European Commission. Consensus Information Paper 2013. What you need to know about biosimilar medicinal products. Available at: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf (accessed 5 October 2014).
-
-
-
-
57
-
-
84870284603
-
Biosimilars in rheumatology: pharmacological and pharmacoeconomic issues
-
Lapadula G, Ferraccioli GF. Biosimilars in rheumatology: pharmacological and pharmacoeconomic issues. Clin Exp Rheumatol 2012; 30: S102-6.
-
(2012)
Clin Exp Rheumatol
, vol.30
, pp. S102-S106
-
-
Lapadula, G.1
Ferraccioli, G.F.2
-
59
-
-
84904338227
-
Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries
-
Brodszky V, Baji P, Balogh O, Pentek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ 2014; 15(Suppl. 1): S65-71.
-
(2014)
Eur J Health Econ
, vol.15
, pp. S65-S71
-
-
Brodszky, V.1
Baji, P.2
Balogh, O.3
Pentek, M.4
-
60
-
-
84942250284
-
5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany
-
abstract 1166).
-
Kim J, Hong J, Kudrin A. 5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany. Arthritis Rheumatol 2014; 11(Suppl.): S512. (abstract 1166).
-
(2014)
Arthritis Rheumatol
, vol.11
, pp. S512
-
-
Kim, J.1
Hong, J.2
Kudrin, A.3
-
61
-
-
84901926678
-
Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland
-
PMS22).
-
McCarthy G, Ebel BC, Guy H. Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland. Value Health 2013; 16: A558. (PMS22).
-
(2013)
Value Health
, vol.16
, pp. A558
-
-
McCarthy, G.1
Ebel, B.C.2
Guy, H.3
-
62
-
-
84884283941
-
Clinical experience with Zarzio(R) in Europe: what have we learned?
-
Gascon P, Tesch H, Verpoort K et al. Clinical experience with Zarzio(R) in Europe: what have we learned? Support Care Cancer 2013; 21: 2925-32.
-
(2013)
Support Care Cancer
, vol.21
, pp. 2925-2932
-
-
Gascon, P.1
Tesch, H.2
Verpoort, K.3
-
63
-
-
84899435760
-
Pharmacoeconomics of cancer therapies: considerations with the introduction of biosimilars
-
Henry D, Taylor C. Pharmacoeconomics of cancer therapies: considerations with the introduction of biosimilars. Semin Oncol 2014; 41(Suppl. 3): S13-20.
-
(2014)
Semin Oncol
, vol.41
, pp. S13-S20
-
-
Henry, D.1
Taylor, C.2
-
64
-
-
0035846326
-
Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent
-
Keane J, Gershon S, Wise RP et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001; 345: 1098-104.
-
(2001)
N Engl J Med
, vol.345
, pp. 1098-1104
-
-
Keane, J.1
Gershon, S.2
Wise, R.P.3
-
65
-
-
84949629897
-
-
World Health Organization. Biological Qualifier. An INN Proposal. Programme on International Nonproprietary Names (INN). INN Working Doc. 14.342. Revised draft July 2014. (accessed 18 November 2014).
-
World Health Organization. Biological Qualifier. An INN Proposal. Programme on International Nonproprietary Names (INN). INN Working Doc. 14.342. Revised draft July 2014. Available at: http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf?ua=1 (accessed 18 November 2014).
-
-
-
-
66
-
-
84949629898
-
-
European Medicines Agency. Report on organisational mattters; Committee for Medicinal Products for Human Use (CHMP) meeting, 22-25 September 2014. (accessed 18 November 2014).
-
European Medicines Agency. Report on organisational mattters; Committee for Medicinal Products for Human Use (CHMP) meeting, 22-25 September 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Annex_to_CHMP_highlights/2014/10/WC500175252.pdf (accessed 18 November 2014).
-
-
-
-
67
-
-
84949623876
-
Patient perspectives on the introduction of subsequent entry biologics in Canada
-
abstract 1507).
-
Sekhon S, Rai R, McClory D et al. Patient perspectives on the introduction of subsequent entry biologics in Canada. Arthritis Rheumatol 2014; 11(Suppl.): S663 (abstract 1507).
-
(2014)
Arthritis Rheumatol
, vol.11
, pp. S663
-
-
Sekhon, S.1
Rai, R.2
McClory, D.3
-
69
-
-
84949629899
-
-
National Rheumatoid Arthritis Society. NRAS position paper on biosimilar medicines. 14 August 2014. (accessed 23 October 2014).
-
National Rheumatoid Arthritis Society. NRAS position paper on biosimilar medicines. 14 August 2014. Available at: http://www.nras.org.uk/data/files/About%20RA/How%20is%20RA%20managed/NRAS%20Biosimilars%20Position%20Paper%20Final.pdf (accessed 23 October 2014).
-
-
-
-
70
-
-
84894901966
-
Burden of disease in treated rheumatoid arthritis patients: going beyond the joint
-
Cutolo M, Kitas GD, van Riel PL. Burden of disease in treated rheumatoid arthritis patients: going beyond the joint. Semin Arthritis Rheum 2014; 43: 479-88.
-
(2014)
Semin Arthritis Rheum
, vol.43
, pp. 479-488
-
-
Cutolo, M.1
Kitas, G.D.2
van Riel, P.L.3
-
71
-
-
84949629900
-
-
Australian Government. Department of Health. Therapeutic Goods Administration. Evaluation of biosimilars. Version 1.0. (accessed 10 August 2015).
-
Australian Government. Department of Health. Therapeutic Goods Administration. Evaluation of biosimilars. Version 1.0. Available at: https://www.tga.gov.au/evaluation-biosimilars (accessed 10 August 2015).
-
-
-
-
72
-
-
84949629901
-
-
Health Canada. Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), (accessed 20 October 2014).
-
Health Canada. Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), 2010. Available at: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf (accessed 20 October 2014).
-
(2010)
-
-
-
73
-
-
84949629902
-
-
Government of India, Department of Biotechnology, Ministry of Science & Technology, Central Drugs Standard Control Organization, Ministry of Health & Family Welfare. Guidelines on Similar Biologics. Regulatory Requirements for Marketing Authorization in India (accessed 20 October 2014).
-
Government of India, Department of Biotechnology, Ministry of Science & Technology, Central Drugs Standard Control Organization, Ministry of Health & Family Welfare. Guidelines on Similar Biologics. Regulatory Requirements for Marketing Authorization in India. 2012. Available at: http://dbtbiosafety.nic.in/Files/CDSCO-DBTSimilarBiologicsfinal.pdf (accessed 20 October 2014).
-
(2012)
-
-
-
74
-
-
85008244662
-
Biosimilar development and regulation in Japan
-
GaBI Journal Editor
-
GaBI Journal Editor. Biosimilar development and regulation in Japan. Generics Biosimilars Initiat J 2013; 2: 207-8.
-
(2013)
Generics Biosimilars Initiat J
, vol.2
, pp. 207-208
-
-
-
75
-
-
84949629903
-
-
South Korean guidelines for biosimilars GaBI online. (accessed 20 October 2014).
-
South Korean guidelines for biosimilars. 2012. GaBI online. Available at: http://www.gabionline.net/Guidelines/South-Korean-guidelines-for-biosimilars (accessed 20 October 2014).
-
(2012)
-
-
-
76
-
-
84962750831
-
-
U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER). Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product. Guidance for Industry (accessed 22 May 2015).
-
U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER). Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product. Guidance for Industry. 2015. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf (accessed 22 May 2015).
-
(2015)
-
-
-
77
-
-
0034888069
-
Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis
-
Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum 2001; 44: 1876-86.
-
(2001)
Arthritis Rheum
, vol.44
, pp. 1876-1886
-
-
Anderson, J.J.1
Baron, G.2
van der Heijde, D.3
Felson, D.T.4
Dougados, M.5
|