-
1
-
-
84863435547
-
The advent of biosimilar therapies in rheumatology—“O brave new world”
-
Scheinberg, M.A., Kay, J., The advent of biosimilar therapies in rheumatology—“O brave new world”. Nat Rev Rheumatol 8 (2012), 430–436.
-
(2012)
Nat Rev Rheumatol
, vol.8
, pp. 430-436
-
-
Scheinberg, M.A.1
Kay, J.2
-
2
-
-
84883746643
-
Biosimilars to treat inflammatory arthritis: the challenge of proving identity
-
Kay, J., Smolen, J.S., Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis 72 (2013), 1589–1593.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1589-1593
-
-
Kay, J.1
Smolen, J.S.2
-
3
-
-
84873635799
-
The role of biosimilars in the treatment of rheumatic diseases
-
Dorner, T., Strand, V., Castaneda-Hernandez, G., Ferraccioli, G., Isaacs, J.D., Kvien, T.K., et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 72 (2013), 322–328.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 322-328
-
-
Dorner, T.1
Strand, V.2
Castaneda-Hernandez, G.3
Ferraccioli, G.4
Isaacs, J.D.5
Kvien, T.K.6
-
4
-
-
84862935674
-
Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know
-
Strober, B.E., Armour, K., Romiti, R., Smith, C., Tebbey, P.W., Menter, A., et al. Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know. J Am Acad Dermatol 66 (2012), 317–322.
-
(2012)
J Am Acad Dermatol
, vol.66
, pp. 317-322
-
-
Strober, B.E.1
Armour, K.2
Romiti, R.3
Smith, C.4
Tebbey, P.W.5
Menter, A.6
-
5
-
-
85033335869
-
-
Assessment report. Inflectra; [accessed 08.04.14]
-
European Medicines Agency. Assessment report. Inflectra, 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf〉; 2013 [accessed 08.04.14].
-
(2013)
-
-
-
6
-
-
85033341150
-
-
Assessment report. Remsima; [accessed 09.04.14]
-
European Medicines Agency. Assessment report. Remsima, 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf〉; 2013 [accessed 09.04.14].
-
(2013)
-
-
-
7
-
-
85033356615
-
-
Epirus’ Remicade biosimilar receives final approvals in India. Epirus Biopharmaceuticals; 2014 [accessed 18.12.14].
-
Epirus’ Remicade biosimilar receives final approvals in India. Epirus Biopharmaceuticals, 〈http://ir.epirusbiopharma.com/releasedetail.cfm?releaseid=870875〉; 2014 [accessed 18.12.14].
-
-
-
-
8
-
-
85033348635
-
-
Celltrion's Remsima (infliximab) receives marketing approval in Japan. Celltrion; 2014 [accessed 18.12.14].
-
Celltrion's Remsima (infliximab) receives marketing approval in Japan. Celltrion, 〈http://www.celltrion.com/en/company/notice_view.asp?idx=451&code=ennews&intNowPage=1&menu_num=&align_year=all〉; 2014 [accessed 18.12.14].
-
-
-
-
9
-
-
85033347824
-
-
Celltrion's Remsima receives Turkey Ministry of Health approval. Celltrion; 2014 [accessed 18.12.14].
-
Celltrion's Remsima receives Turkey Ministry of Health approval. Celltrion, 〈http://www.celltrion.com/en/company/notice_view.asp?idx=452&code=ennews&intNowPage=1&menu_num=&align_year=all〉; 2014 [accessed 18.12.14].
-
-
-
-
10
-
-
85033351117
-
-
Di Biase S. IMS Health. Searching for terra firma in the biosimilars and non-original biologics market. Insights for the coming decade of change.; 2013 [accessed 02.04.14].
-
Rickwood S, Di Biase S. IMS Health. Searching for terra firma in the biosimilars and non-original biologics market. Insights for the coming decade of change. 〈http://www.imshealth.com/cds/imshealth/Global/Content/Healthcare/Life%20Sciences%20Solutions/Generics/IMSH_Biosimilars_WP.pdf〉; 2013 [accessed 02.04.14].
-
-
-
Rickwood, S.1
-
11
-
-
85033344237
-
-
Assessing biosimilar uptake and competition in European markets. I; [accessed 08.12.14]
-
IMS Institute for Health Informatics. Assessing biosimilar uptake and competition in European markets. I, 〈http://www.imshealth.com/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Insights/Assessing_biosimilar_uptake_and_competition_in_European_markets.pdf〉; 2014 [accessed 08.12.14].
-
(2014)
-
-
-
12
-
-
0036499495
-
‘Biogenerics’: the off-patent biotech products
-
Schellekens, H., Ryff, J.C., ‘Biogenerics’: the off-patent biotech products. Trends Pharmacol Sci 23 (2002), 119–121.
-
(2002)
Trends Pharmacol Sci
, vol.23
, pp. 119-121
-
-
Schellekens, H.1
Ryff, J.C.2
-
13
-
-
77954653769
-
Characterization of the glycosylation occupancy and the active site in the follow-on protein therapeutic: TNK-tissue plasminogen activator
-
Jiang, H., Wu, S.L., Karger, B.L., Hancock, W.S., Characterization of the glycosylation occupancy and the active site in the follow-on protein therapeutic: TNK-tissue plasminogen activator. Anal Chem 82 (2010), 6154–6162.
-
(2010)
Anal Chem
, vol.82
, pp. 6154-6162
-
-
Jiang, H.1
Wu, S.L.2
Karger, B.L.3
Hancock, W.S.4
-
14
-
-
84895525056
-
®) with those of an alleged biosimilar
-
®) with those of an alleged biosimilar. Front Pharmacol, 5, 2014, 7.
-
(2014)
Front Pharmacol
, vol.5
, pp. 7
-
-
Kliche, W.1
Krech, I.2
Michel, M.C.3
Sangole, N.V.4
Sathaye, S.5
-
15
-
-
84872175228
-
Biosimilar monoclonal antibodies: a science-based regulatory challenge
-
Declerck, P.J., Biosimilar monoclonal antibodies: a science-based regulatory challenge. Expert Opin Biol Ther 13 (2013), 153–156.
-
(2013)
Expert Opin Biol Ther
, vol.13
, pp. 153-156
-
-
Declerck, P.J.1
-
16
-
-
84876701598
-
Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label study
-
Nash, P., Nayiager, S., Genovese, M.C., Kivitz, A.J., Oelle, K., Ludivico, C., et al. Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label study. Arthritis Care Res (Hoboken) 65 (2013), 718–728.
-
(2013)
Arthritis Care Res (Hoboken)
, vol.65
, pp. 718-728
-
-
Nash, P.1
Nayiager, S.2
Genovese, M.C.3
Kivitz, A.J.4
Oelle, K.5
Ludivico, C.6
-
19
-
-
85033356964
-
-
Guidance for industry. Scientific considerations in demonstrating biosimilarity to a reference product; [accessed 21.05.14]
-
US Food and Drug Administration. Guidance for industry. Scientific considerations in demonstrating biosimilarity to a reference product, 〈http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf〉; 2012 [accessed 21.05.14].
-
(2012)
-
-
-
20
-
-
85033341148
-
-
Guidance for industry. Assay development for immunogenicity testing of therapeutic proteins; [accessed 14.04.14]
-
US Food and Drug Administration. Guidance for industry. Assay development for immunogenicity testing of therapeutic proteins, 〈http://www.fda.gov/downloads/Drugs/…/Guidances/UCM192750.pdf〉; 2009 [accessed 14.04.14].
-
(2009)
-
-
-
21
-
-
85033351831
-
-
Patient Protection and Affordable Care Act. Congress of the United States of America; 2010 [accessed 18.12.13].
-
Patient Protection and Affordable Care Act. Congress of the United States of America, 〈http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf〉; 2010 [accessed 18.12.13].
-
-
-
-
22
-
-
0036598634
-
Bioequivalence and the immunogenicity of biopharmaceuticals
-
Schellekens, H., Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 1 (2002), 457–462.
-
(2002)
Nat Rev Drug Discov
, vol.1
, pp. 457-462
-
-
Schellekens, H.1
-
23
-
-
84866933842
-
Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development
-
Cai, X.Y., Thomas, J., Cullen, C., Gouty, D., Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development. Bioanalysis 4 (2012), 2169–2177.
-
(2012)
Bioanalysis
, vol.4
, pp. 2169-2177
-
-
Cai, X.Y.1
Thomas, J.2
Cullen, C.3
Gouty, D.4
-
26
-
-
85033328417
-
-
Guidance for industry. Immunogenicity assessment for therapeutic protein products; [accessed 14.04.14]
-
US Food and Drug Administration. Guidance for industry. Immunogenicity assessment for therapeutic protein products, 〈http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf〉; 2013 [accessed 14.04.14].
-
(2013)
-
-
-
27
-
-
84896883598
-
Biosimilars: how similar?
-
Strand, V., Cronstein, B., Biosimilars: how similar?. Intern Med J 44 (2014), 218–223.
-
(2014)
Intern Med J
, vol.44
, pp. 218-223
-
-
Strand, V.1
Cronstein, B.2
-
28
-
-
84873940514
-
Understanding and incentivizing biosimilars
-
Kanter, J., Feldman, R., Understanding and incentivizing biosimilars. Hastings Law J 64 (2012), 57–82.
-
(2012)
Hastings Law J
, vol.64
, pp. 57-82
-
-
Kanter, J.1
Feldman, R.2
-
29
-
-
40149095089
-
The challenge of biosimilars
-
Mellstedt, H., Niederwieser, D., Ludwig, H., The challenge of biosimilars. Ann Oncol 19 (2008), 411–419.
-
(2008)
Ann Oncol
, vol.19
, pp. 411-419
-
-
Mellstedt, H.1
Niederwieser, D.2
Ludwig, H.3
-
30
-
-
84887489815
-
The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis
-
Garces, S., Demengeot, J., Benito-Garcia, E., The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis 72 (2013), 1947–1955.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1947-1955
-
-
Garces, S.1
Demengeot, J.2
Benito-Garcia, E.3
-
31
-
-
33644931095
-
Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis
-
Wolbink, G.J., Vis, M., Lems, W., Voskuyl, A.E., deGroot, E., Nurmohamed, M.T., et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 54 (2006), 711–715.
-
(2006)
Arthritis Rheum
, vol.54
, pp. 711-715
-
-
Wolbink, G.J.1
Vis, M.2
Lems, W.3
Voskuyl, A.E.4
deGroot, E.5
Nurmohamed, M.T.6
-
32
-
-
84870385642
-
Comparison of long-term clinical outcome with etanercept treatment and adalimumab treatment of rheumatoid arthritis with respect to immunogenicity
-
Krieckaert, C.L., Jamnitski, A., Nurmohamed, M.T., Kostense, P.J., Boers, M., Wolbink, G., Comparison of long-term clinical outcome with etanercept treatment and adalimumab treatment of rheumatoid arthritis with respect to immunogenicity. Arthritis Rheum 64 (2012), 3850–3855.
-
(2012)
Arthritis Rheum
, vol.64
, pp. 3850-3855
-
-
Krieckaert, C.L.1
Jamnitski, A.2
Nurmohamed, M.T.3
Kostense, P.J.4
Boers, M.5
Wolbink, G.6
-
33
-
-
0031660364
-
Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis
-
Maini, R.N., Breedveld, F.C., Kalden, J.R., Smolen, J.S., Davis, D., Macfarlane, J.D., et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 41 (1998), 1552–1563.
-
(1998)
Arthritis Rheum
, vol.41
, pp. 1552-1563
-
-
Maini, R.N.1
Breedveld, F.C.2
Kalden, J.R.3
Smolen, J.S.4
Davis, D.5
Macfarlane, J.D.6
-
34
-
-
84932610445
-
Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial
-
Burmester, G.R., Kivitz, A.J., Kupper, H., Arulmani, U., Florentinus, S., Goss, S.L., et al. Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial. Ann Rheum Dis, 2014 〈http://dx.doi.org/10.1136/annrheumdis-2013-204769〉.
-
(2014)
Ann Rheum Dis
-
-
Burmester, G.R.1
Kivitz, A.J.2
Kupper, H.3
Arulmani, U.4
Florentinus, S.5
Goss, S.L.6
-
35
-
-
85033333323
-
-
ClinicalTrials gov. A study to determine the effect of methotrexate (MTX) dose on clinical outcome and ultrasonographic signs in subjects with moderately to severely active rheumatoid arthritis (RA) treated with adalimumab (MUSICA); 2014 [accessed 18.12.14].
-
ClinicalTrials gov. A study to determine the effect of methotrexate (MTX) dose on clinical outcome and ultrasonographic signs in subjects with moderately to severely active rheumatoid arthritis (RA) treated with adalimumab (MUSICA), 〈https://clinicaltrials.gov/ct2/show/results/NCT01185288?sect=X7#limit〉; 2014 [accessed 18.12.14].
-
-
-
-
37
-
-
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 29 (2011), 310–312.
-
(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
-
38
-
-
85033353530
-
-
Guidance for industry. Quality considerations in demonstrating biosimilarity to a reference protein product; [accessed 21.05.14]
-
US Food and Drug Administration. Guidance for industry. Quality considerations in demonstrating biosimilarity to a reference protein product, 〈http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf〉; 2012 [accessed 21.05.14].
-
(2012)
-
-
-
39
-
-
85033333366
-
-
Guidance for industry. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product; [accessed 19.05.14]
-
US Food and Drug Administration. Guidance for industry. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product, 〈http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm397017.pdf〉; 2014 [accessed 19.05.14].
-
(2014)
-
-
-
40
-
-
85033335098
-
-
Safety assessment of biosimilars in Europe: a regulatory perspective, [accessed 23.12.14].
-
Giezen TJ, Schneider CK. Safety assessment of biosimilars in Europe: a regulatory perspective, 〈http://gabi-journal.net/safety-assessment-of-biosimilars-in-europe-a-regulatory-perspective.html〉, 2014 [accessed 23.12.14].
-
(2014)
-
-
Giezen, T.J.1
Schneider, C.K.2
-
41
-
-
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., Kovalenko, V., Lysenko, G., Miranda, P., 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 72 (2013), 1605–1612.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1605-1612
-
-
Park, W.1
Hrycaj, P.2
Jeka, S.3
Kovalenko, V.4
Lysenko, G.5
Miranda, P.6
-
42
-
-
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, D.H., Hrycaj, P., Miranda, P., Ramiterre, E., Piotrowski, M., Shevchuk, S., 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 72 (2013), 1613–1620.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1613-1620
-
-
Yoo, D.H.1
Hrycaj, P.2
Miranda, P.3
Ramiterre, E.4
Piotrowski, M.5
Shevchuk, S.6
-
43
-
-
85033342331
-
-
Inhibition of radiographic progression and its association with clinical parameters in RA patients treated with CT-P13 and innovator infliximab in PLANETRA study. Paper presented at 2014 Annual European Congress of Rheumatology. Paris, France; June 11–14.
-
Yoo D, Park W, Miranda P, Piotrowski M, Ramiterre E, Shevchuk S, et al. Inhibition of radiographic progression and its association with clinical parameters in RA patients treated with CT-P13 and innovator infliximab in PLANETRA study. Paper presented at 2014 Annual European Congress of Rheumatology. Paris, France; June 11–14, 2014.
-
(2014)
-
-
Yoo, D.1
Park, W.2
Miranda, P.3
Piotrowski, M.4
Ramiterre, E.5
Shevchuk, S.6
-
44
-
-
84901920947
-
A review of CT-P13: an infliximab biosimilar
-
McKeage, K., A review of CT-P13: an infliximab biosimilar. BioDrugs, 2014 〈http://dx.doi.org/10.1007/s40259-014-0094-1〉.
-
(2014)
BioDrugs
-
-
McKeage, K.1
-
46
-
-
85033352622
-
-
Guidance for industry. Good pharmacovigilance practices and pharmacoepidemiologic assessment; [accessed 01.05.14]
-
US Food and Drug Administration. Guidance for industry. Good pharmacovigilance practices and pharmacoepidemiologic assessment, 〈http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf〉; 2005 [accessed 01.05.14].
-
(2005)
-
-
-
47
-
-
85033346494
-
-
The future of biosimilar use and regulation in Latin America. GaBI Online; 2014 [accessed 22.12.14].
-
The future of biosimilar use and regulation in Latin America. GaBI Online, 〈http://www.gabionline.net/Biosimilars/Research/The-future-of-biosimilar-use-and-regulation-in-Latin-America〉; 2014 [accessed 22.12.14].
-
-
-
-
48
-
-
85033340979
-
-
InTech. Risk management plan and pharmacovigilance system- biopharmaceuticals: biosimilars; 2011 [accessed 01.05.14].
-
Calvo B, Zuniga L. InTech. Risk management plan and pharmacovigilance system- biopharmaceuticals: biosimilars, 〈http://www.intechopen.com/books/risk-management-trends/risk-managementplan-and-pharmacovigilance-system-biopharmaceuticals-biosimilars〉; 2011 [accessed 01.05.14].
-
-
-
Calvo, B.1
Zuniga, L.2
-
50
-
-
80053493531
-
Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate
-
Genovese, M.C., Covarrubias, A., Leon, G., Mysler, E., Keisermann, M., Valente, R., et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum 63 (2011), 2854–2864.
-
(2011)
Arthritis Rheum
, vol.63
, pp. 2854-2864
-
-
Genovese, M.C.1
Covarrubias, A.2
Leon, G.3
Mysler, E.4
Keisermann, M.5
Valente, R.6
-
51
-
-
84860916327
-
Abatacept in subjects who switch from intravenous to subcutaneous therapy: results from the phase IIIb ATTUNE study
-
Keystone, E.C., Kremer, J.M., Russell, A., Box, J., Abud-Mendoza, C., Elizondo, M.G., et al. Abatacept in subjects who switch from intravenous to subcutaneous therapy: results from the phase IIIb ATTUNE study. Ann Rheum Dis 71 (2012), 857–861.
-
(2012)
Ann Rheum Dis
, vol.71
, pp. 857-861
-
-
Keystone, E.C.1
Kremer, J.M.2
Russell, A.3
Box, J.4
Abud-Mendoza, C.5
Elizondo, M.G.6
-
52
-
-
84883159838
-
Pharmacokinetics and pharmacodynamics of tocilizumab after subcutaneous administration in patients with rheumatoid arthritis
-
Zhang, X., Chen, Y.C., Fettner, S., Rowell, L., Gott, T., Grimsey, P., et al. Pharmacokinetics and pharmacodynamics of tocilizumab after subcutaneous administration in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther 51 (2013), 620–630.
-
(2013)
Int J Clin Pharmacol Ther
, vol.51
, pp. 620-630
-
-
Zhang, X.1
Chen, Y.C.2
Fettner, S.3
Rowell, L.4
Gott, T.5
Grimsey, P.6
-
53
-
-
84889667445
-
A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study)
-
Burmester, G.R., Rubbert-Roth, A., Cantagrel, A., Hall, S., Leszczynski, P., Feldman, D., et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis 73 (2014), 69–74.
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 69-74
-
-
Burmester, G.R.1
Rubbert-Roth, A.2
Cantagrel, A.3
Hall, S.4
Leszczynski, P.5
Feldman, D.6
-
54
-
-
84896689880
-
Phase III study of the efficacy and safety of subcutaneous versus intravenous tocilizumab monotherapy in patients with rheumatoid arthritis
-
Ogata, A., Tanimura, K., Sugimoto, T., Inoue, H., Urata, Y., Matsubara, T., et al. Phase III study of the efficacy and safety of subcutaneous versus intravenous tocilizumab monotherapy in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken) 66 (2014), 344–354.
-
(2014)
Arthritis Care Res (Hoboken)
, vol.66
, pp. 344-354
-
-
Ogata, A.1
Tanimura, K.2
Sugimoto, T.3
Inoue, H.4
Urata, Y.5
Matsubara, T.6
-
55
-
-
85033346576
-
-
State laws and legislation related to biologic medications and substitution of biosimilars. National Conference of State Legislatures; 2014 [accessed 03.09.14].
-
State laws and legislation related to biologic medications and substitution of biosimilars. National Conference of State Legislatures, 〈http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx〉; 2014 [accessed 03.09.14].
-
-
-
-
56
-
-
85033359237
-
-
57th Consultation on International Nonproprietary Names for Pharmaceutical Substances, Geneva, 22–24 October 2013. Executive summary; [accessed 02.05.14]
-
World Health Organization. 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances, Geneva, 22–24 October 2013. Executive summary, 〈http://www.who.int/medicines/services/inn/57th_Executive_Summary.pdf?ua=1〉; 2013 [accessed 02.05.14].
-
(2013)
-
-
-
57
-
-
85033335183
-
-
[accessed 02.05.14]
-
US Food and Drug Administration. How FDA reviews proposed drug names, 〈http://www.fda.gov/downloads/Drugs/DrugSafety/MedicationErrors/ucm080867.pdf〉; 2014 [accessed 02.05.14].
-
(2014)
How FDA reviews proposed drug names
-
-
-
58
-
-
85033333606
-
-
56th Consultation on International Nonproprietary Names for Pharmaceutical Substances, Geneva, 15–17 April 2013. Executive summary; [accessed 02.05.14]
-
World Health Organization. 56th Consultation on International Nonproprietary Names for Pharmaceutical Substances, Geneva, 15–17 April 2013. Executive summary, 〈http://www.who.int/medicines/services/inn/56th_Executive_Summary.pdf?ua=1〉; 2013 [accessed 02.05.14].
-
(2013)
-
-
-
59
-
-
85033350283
-
-
Biological qualifier. An INN proposal; [accessed 22.12.14]
-
World Health Organization. Biological qualifier. An INN proposal, 〈http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf〉; 2014 [accessed 22.12.14].
-
(2014)
-
-
|