-
1
-
-
85018187837
-
Geneva, 19 to 23 October 2009
-
WHO, World Health Organization. Expert Committee on Biological Standardization. Geneva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Accessed 19 Feb 2015.
-
(2009)
Guidelines on evaluation of similar biotherapeutic products (SBPs)
-
-
-
2
-
-
84982223125
-
Committee for Medicinal Products for Human Use (CHMP)
-
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on Similar Biological Medicine Products (CHMP/437/04 Rev 1). 23 October 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed 2 Jul 2015.
-
(2014)
Guideline on Similar Biological Medicine Products (CHMP/437/04 Rev
, vol.1
, pp. 23
-
-
-
4
-
-
84904069611
-
The challenge of indication extrapolation for infliximab biosimilars
-
COI: 1:CAS:528:DC%2BC2cXhtVaktb%2FM, PID: 24962198
-
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
-
5
-
-
84913533583
-
Physicochemical characterization of Remsima
-
PID: 25517302
-
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
-
6
-
-
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
-
COI: 1:CAS:528:DC%2BC3sXhs1eis7nM, PID: 23687259
-
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
-
7
-
-
84870933584
-
Interchangeability, immunogenicity and biosimilars
-
COI: 1:CAS:528:DC%2BC38Xhsl2ltbnO, PID: 23222784
-
Ebbers HC, Crow SA, Vulto AG, et al. 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
-
8
-
-
84905717145
-
Statistical and regulatory considerations in assessments of interchangeability of biological drug products
-
PID: 24832831
-
Tóthfalusi L, Endrényi 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-S11
-
-
Tóthfalusi, L.1
Endrényi, L.2
Chow, S.C.3
-
9
-
-
85018173809
-
AIFA: Position paper. I farmaci biosimilari. 13/05/2013
-
AIFA: Position paper. I farmaci biosimilari. 13/05/2013.
-
-
-
-
10
-
-
84928705954
-
Position paper of Italian rheumatologists on the use of biosimilar drugs
-
PID: 25436597
-
Atzeni F, Sebastiani M, Ricci C, Celano A, Gremese E, Iannone F, et al. Position paper of Italian rheumatologists on the use of biosimilar drugs. Clin Exp Rheumatol. 2015;33(1):1–4.
-
(2015)
Clin Exp Rheumatol
, vol.33
, Issue.1
, pp. 1-4
-
-
Atzeni, F.1
Sebastiani, M.2
Ricci, C.3
Celano, A.4
Gremese, E.5
Iannone, F.6
-
11
-
-
84965014483
-
Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study
-
Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Ureña S, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2016. doi:10.1136/annrheumdis-2015-208783.
-
(2016)
Ann Rheum Dis
-
-
Park, W.1
Yoo, D.H.2
Miranda, P.3
Brzosko, M.4
Wiland, P.5
Gutierrez-Ureña, S.6
-
12
-
-
84978795758
-
Infliximab and CT-P13 immunogenicity assessment in PLANETAS and PLANETRAS main and extension studies: utility of laboratory methods description
-
Meacci F, Manfredi M, Infantino M, Grossi V, Benucci M. Infliximab and CT-P13 immunogenicity assessment in PLANETAS and PLANETRAS main and extension studies: utility of laboratory methods description. Ann Rheum Dis. 2016. doi:10.1136/annrheumdis-2016-210078.
-
(2016)
Ann Rheum Dis
-
-
Meacci, F.1
Manfredi, M.2
Infantino, M.3
Grossi, V.4
Benucci, M.5
-
13
-
-
84961838400
-
-
Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars, Ann Rheum Dis
-
Ruiz-Argüello MB, Maguregui A, Ruiz Del Agua A, Pascual-Salcedo D, Martínez-Feito A, Jurado T, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars. Ann Rheum Dis. 2016
-
(2016)
et al
-
-
Ruiz-Argüello, M.B.1
Maguregui, A.2
Ruiz Del Agua, A.3
Pascual-Salcedo, D.4
Martínez-Feito, A.5
Jurado, T.6
-
14
-
-
84964608856
-
Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health
-
PID: 27117857
-
Braun J, Kudrin A. Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health. Biologicals. 2016;44(4):257–66. doi:10.1016/j.biologicals.2016.03.006.
-
(2016)
Biologicals
, vol.44
, Issue.4
, pp. 257-266
-
-
Braun, J.1
Kudrin, A.2
-
15
-
-
84940081554
-
Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study
-
COI: 1:CAS:528:DC%2BC2MXhvFCqtr%2FF, PID: 25974251
-
Jung YS, Park DI, Kim YH, Lee JH, Seo PJ, Cheon JH, 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;30(12):1705–12. doi:10.1111/jgh.12997.
-
(2015)
J Gastroenterol Hepatol
, vol.30
, Issue.12
, pp. 1705-1712
-
-
Jung, Y.S.1
Park, D.I.2
Kim, Y.H.3
Lee, J.H.4
Seo, P.J.5
Cheon, J.H.6
-
16
-
-
84942325078
-
Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea
-
Park SH, Kim YH, Lee JH, Kwon HJ, Lee SH, Park DI, et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol. 2015;9(Suppl. 1):35e44.
-
(2015)
Expert Rev Gastroenterol Hepatol
, vol.9
, pp. 35e44
-
-
Park, S.H.1
Kim, Y.H.2
Lee, J.H.3
Kwon, H.J.4
Lee, S.H.5
Park, D.I.6
-
17
-
-
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. 2015;60:6.
-
(2015)
Dig Dis Sci
, vol.60
, pp. 6
-
-
Kang, Y.S.1
Moon, H.H.2
Lee, S.E.3
Lim, Y.J.4
Kang, H.W.5
-
18
-
-
85011663828
-
Jarze˛bicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska A, et al. Switching between infliximab originator and biosimilar in pediatric patients with inflammatory bowel disease. Preliminary observation
-
Sieczkowska J, Jarze˛bicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska A, et al. Switching between infliximab originator and biosimilar in pediatric patients with inflammatory bowel disease. Preliminary observation. J Crohns Colitis. 2016;10(2):127–32. doi:10.1093/ecco-jcc/jjv233.
-
(2016)
J Crohns Colitis
, vol.10
, Issue.2
, pp. 127-132
-
-
Sieczkowska, J.1
-
19
-
-
84946601256
-
Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data
-
COI: 1:CAS:528:DC%2BC2MXhvVSltL3N, PID: 26549204
-
Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, et al. Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15:1677–83.
-
(2015)
Expert Opin Biol Ther
, vol.15
, pp. 1677-1683
-
-
Nikiphorou, E.1
Kautiainen, H.2
Hannonen, P.3
Asikainen, J.4
Kokko, A.5
Rannio, T.6
-
20
-
-
84976339013
-
Switch from Infliximab to Infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseases
-
Gentileschi S, Barreca C, Bellisai F, Biasi G, Brizi MG, de Stefano R, et al. Switch from Infliximab to Infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseases. Expert Opin Biol Ther. 2016. doi:10.1080/14712598.2016.1198765.
-
(2016)
Expert Opin Biol Ther
-
-
Gentileschi, S.1
Barreca, C.2
Bellisai, F.3
Biasi, G.4
Brizi, M.G.5
de Stefano, R.6
|