-
1
-
-
84884381595
-
-
Process on Corporate Responsibility in the Field of Pharmaceuticals Access to Medicines in Europe, A Consensus Information Document
-
European Commission, DG Enterprise and industry. What you Need to Know about Biosimilar Medicinal Products. Process on Corporate Responsibility in the Field of Pharmaceuticals Access to Medicines in Europe. A Consensus Information Document, 2013. http://europa.eu/geninfo/query/resultaction.jsp?query_source=GROWTH&QueryText=biosimilars&op=Search&swlang=en&form_build_id=form-CA4kk1hS9th2Qw_AyEvYWFKAUUlCNvY6kFflINvXlD4&form_id=nexteuropa_europa_search_search_form. Accessed 30 Sept 2016.
-
(2013)
What you Need to Know about Biosimilar Medicinal Products
-
-
-
2
-
-
84899412968
-
Biosimilars in oncology: from development to clinical practice
-
PID: 24767633
-
Rak Tkaczuk K, Jacobs I. Biosimilars in oncology: from development to clinical practice. Semin Oncol. 2014;41(Suppl 3):S3–12.
-
(2014)
Semin Oncol
, vol.41
, pp. S3-S12
-
-
Rak Tkaczuk, K.1
Jacobs, I.2
-
4
-
-
84870933584
-
Interchangeability, immunogenicity and biosimilars
-
COI: 1:CAS:528:DC%2BC38Xhsl2ltbnO, PID: 23222784
-
Ebbers H, Crow S, Vulto A, Schellekens H. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol. 2012;30:1186–90.
-
(2012)
Nat Biotechnol
, vol.30
, pp. 1186-1190
-
-
Ebbers, H.1
Crow, S.2
Vulto, A.3
Schellekens, H.4
-
5
-
-
84900459730
-
Biosimilars in the therapy of inflammatory bowel diseases
-
COI: 1:CAS:528:DC%2BC2cXnsVSktrY%3D, PID: 24722561
-
Hlavaty T, Letkovsky J. Biosimilars in the therapy of inflammatory bowel diseases. Eur J Gastroenterol Hepatol. 2014;26:581–687.
-
(2014)
Eur J Gastroenterol Hepatol
, vol.26
, pp. 581-687
-
-
Hlavaty, T.1
Letkovsky, J.2
-
6
-
-
85017010592
-
-
Interchangeability and Physician Notification. Accessed 30 Sept 2016
-
The Alliance for Safe Biologic Medicines (ASBM). Interchangeability and Physician Notification. http://safebiologics.org/resources/in-the-states/. Accessed 30 Sept 2016.
-
(2016)
The Alliance for Safe Biologic Medicines (ASBM)
-
-
-
7
-
-
80051984166
-
Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations
-
COI: 1:CAS:528:DC%2BC3MXhsVKhu7zI, PID: 21861538
-
Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drugs. 2011;71:1527–36.
-
(2011)
Drugs
, vol.71
, pp. 1527-1536
-
-
Dranitsaris, G.1
Amir, E.2
Dorward, K.3
-
8
-
-
84868121869
-
Biologicals and biosimilars: a review of the science and its implications
-
Declerck P. Biologicals and biosimilars: a review of the science and its implications. GaBI J. 2012;1:13–6.
-
(2012)
GaBI J.
, vol.1
, pp. 13-16
-
-
Declerck, P.1
-
9
-
-
84896549088
-
Expert perspectives on biosimilar monoclonal antibodies in breast cancer
-
COI: 1:CAS:528:DC%2BC2cXjtFSlu7s%3D, PID: 24562824
-
Cortes J, Curigliano G, Dieras V. Expert perspectives on biosimilar monoclonal antibodies in breast cancer. Breast Cancer Res Treat. 2014;144:233–9.
-
(2014)
Breast Cancer Res Treat
, vol.144
, pp. 233-239
-
-
Cortes, J.1
Curigliano, G.2
Dieras, V.3
-
10
-
-
84877300355
-
Building a wall against biosimilars
-
No authors listed. Building a wall against biosimilars. Nat Biotechnol. 2013;31:264.
-
(2013)
Nat Biotechnol
, vol.31
, pp. 264
-
-
-
11
-
-
84959042048
-
Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents
-
PID: 26808864
-
Vezér B, Buzás Z, Sebeszta M, Zrubka Z. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents. Curr Med Res Opin. 2016;32:829–34.
-
(2016)
Curr Med Res Opin
, vol.32
, pp. 829-834
-
-
Vezér, B.1
Buzás, Z.2
Sebeszta, M.3
Zrubka, Z.4
-
12
-
-
84982141850
-
-
ICH Q5E, CPMP/ICH/5721/03. Comparability of Biotechnological/Biological Products: Note for guidance on biotechnological/biological products subject to changes in their manufacturing process. Accessed 30 Sept 2016
-
European Medicines Agency (EMA). ICH Q5E, CPMP/ICH/5721/03. Comparability of Biotechnological/Biological Products: Note for guidance on biotechnological/biological products subject to changes in their manufacturing process. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000888.jsp&mid=WC0b01ac058002956b. Accessed 30 Sept 2016.
-
(2016)
European Medicines Agency (EMA)
-
-
-
13
-
-
84982141850
-
-
Guideline on Similar Biological Medicinal Products. Accessed 30 Sept 2016.
-
European Medicines Agency (EMA): Guideline on Similar Biological Medicinal Products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed 30 Sept 2016.
-
(2016)
European Medicines Agency (EMA)
-
-
-
14
-
-
84867307195
-
The safety of switching between therapeutic proteins
-
COI: 1:CAS:528:DC%2BC38XhsV2ktb3L, PID: 22849511
-
Ebbers H, Münzenberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther. 2012;12:1473–85.
-
(2012)
Expert Opin Biol Ther
, vol.12
, pp. 1473-1485
-
-
Ebbers, H.1
Münzenberg, M.2
Schellekens, H.3
-
15
-
-
84926639724
-
The ESA scenario gets complex: from biosimilar epoetins to activin traps
-
PID: 24748667
-
Jelkmann W. The ESA scenario gets complex: from biosimilar epoetins to activin traps. Nephrol Dial Transplant. 2015;30:553–9.
-
(2015)
Nephrol Dial Transplant
, vol.30
, pp. 553-559
-
-
Jelkmann, W.1
-
16
-
-
79961203419
-
Biosimilars: why terminology matters
-
COI: 1:CAS:528:DC%2BC3MXpvVOls74%3D, PID: 21822237
-
Weise M, Bielsky MC, De Smet K, et al. Biosimilars: why terminology matters. Nat Biotechnol. 2011;29(8):690–3.
-
(2011)
Nat Biotechnol
, vol.29
, Issue.8
, pp. 690-693
-
-
Weise, M.1
Bielsky, M.C.2
De Smet, K.3
-
17
-
-
84982141850
-
-
European Public Assessment reports. Accessed 30 Sept 2016.
-
European Medicines Agency (EMA). European Public Assessment reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124. Accessed 30 Sept 2016.
-
(2016)
European Medicines Agency (EMA)
-
-
-
18
-
-
84961880187
-
A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials
-
COI: 1:CAS:528:DC%2BC28XktFGltrY%3D, PID: 26574160
-
Yu Y, Teerenstra S, Neef C, Burger D, Maliepaard M. A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials. Br J Clin Pharmacol. 2016;81(4):667–78.
-
(2016)
Br J Clin Pharmacol.
, vol.81
, Issue.4
, pp. 667-678
-
-
Yu, Y.1
Teerenstra, S.2
Neef, C.3
Burger, D.4
Maliepaard, M.5
-
19
-
-
62949147825
-
-
Immunogenicity assessment of biotechnology-derived therapeutic proteins, rev1. Accessed 1 Sept 2019
-
European Medicines Agency (EMA). Immunogenicity assessment of biotechnology-derived therapeutic proteins, rev1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001391.jsp&mid=WC0b01ac058002958c. Accessed 1 Sept 2019.
-
European Medicines Agency (EMA)
-
-
-
20
-
-
0029162562
-
Comprehensive pharmacokinetics of a humanized antibody and analysis of residual anti-idiotypic responses
-
COI: 1:CAS:528:DyaK2MXns1ylsrg%3D, PID: 7558164
-
Stephens S, Emtage S, Vetterlein O, Chaplin L, Bebbington C, Nesbitt A, et al. Comprehensive pharmacokinetics of a humanized antibody and analysis of residual anti-idiotypic responses. Immunology. 1995;85:668–74.
-
(1995)
Immunology
, vol.85
, pp. 668-674
-
-
Stephens, S.1
Emtage, S.2
Vetterlein, O.3
Chaplin, L.4
Bebbington, C.5
Nesbitt, A.6
-
21
-
-
85017008355
-
Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learned and open questions based on 10 years’ experience of the European Union regulatory pathway
-
Chamberlain P. Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learned and open questions based on 10 years’ experience of the European Union regulatory pathway. Biosimilars. 2014;4:23–43.
-
(2014)
Biosimilars.
, vol.4
, pp. 23-43
-
-
Chamberlain, P.1
-
22
-
-
40849142102
-
Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose
-
COI: 1:CAS:528:DC%2BD1cXjt1aitLk%3D, PID: 18337601
-
Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008;358:1109–17.
-
(2008)
N Engl J Med
, vol.358
, pp. 1109-1117
-
-
Chung, C.H.1
Mirakhur, B.2
Chan, E.3
Le, Q.T.4
Berlin, J.5
Morse, M.6
-
23
-
-
0037075272
-
Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
-
COI: 1:CAS:528:DC%2BD38XhtFCktr8%3D, PID: 11844847
-
Casadevall N, Nataf JM, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002;346:469–75.
-
(2002)
N Engl J Med
, vol.346
, pp. 469-475
-
-
Casadevall, N.1
Nataf, J.M.2
Viron, B.3
-
24
-
-
84961838400
-
Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars
-
PID: 26965981
-
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;75(9):1693–6.
-
(2016)
Ann Rheum Dis
, vol.75
, Issue.9
, pp. 1693-1696
-
-
Ruiz-Argüello, M.B.1
Maguregui, A.2
Ruiz Del Agua, A.3
Pascual-Salcedo, D.4
Martínez-Feito, A.5
Jurado, T.6
-
25
-
-
84973896889
-
Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima
-
PID: 25897019
-
Ben-Horin S, Yavzori M, Benhar I, Fudim E, Picard O, Ungar B, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2016;65(7):1132–8.
-
(2016)
Gut
, vol.65
, Issue.7
, pp. 1132-1138
-
-
Ben-Horin, S.1
Yavzori, M.2
Benhar, I.3
Fudim, E.4
Picard, O.5
Ungar, B.6
-
26
-
-
77649326083
-
Regulation and dysregulation of immunoglobulin E: a molecular and clinical perspective
-
PID: 20178634
-
Pate M, Kelly Smith J, Chi D, Krishnaswamy G. Regulation and dysregulation of immunoglobulin E: a molecular and clinical perspective. Clin Mol Allergy. 2010;8:3.
-
(2010)
Clin Mol Allergy.
, vol.8
, pp. 3
-
-
Pate, M.1
Kelly Smith, J.2
Chi, D.3
Krishnaswamy, G.4
-
28
-
-
0035139983
-
Danger signals: SOS to the immune system
-
COI: 1:CAS:528:DC%2BD3MXhtFChsLc%3D, PID: 11154927
-
Gallucci S, Matzinger P. Danger signals: SOS to the immune system. Curr Opin Immunol. 2001;13:114–9.
-
(2001)
Curr Opin Immunol
, vol.13
, pp. 114-119
-
-
Gallucci, S.1
Matzinger, P.2
-
29
-
-
84887987723
-
Adaptive immune activation: glycosylation does matter
-
COI: 1:CAS:528:DC%2BC3sXhslOlsL3E, PID: 24231619
-
Wolfert MA, Boons G-J. Adaptive immune activation: glycosylation does matter. Nat Chem Biol. 2013;9:776–84.
-
(2013)
Nat Chem Biol
, vol.9
, pp. 776-784
-
-
Wolfert, M.A.1
Boons, G.-J.2
-
30
-
-
84873679430
-
Biosimilars in rheumatology: the wind of change
-
COI: 1:CAS:528:DC%2BC3sXjvFOjtbs%3D, PID: 23390018
-
Schneider C. 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.1
-
31
-
-
70350776252
-
Therapeutic equivalence, long-term and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
-
COI: 1:CAS:528:DC%2BD1MXhs1WisrfL, PID: 19863881
-
Haag-Weber M, Vetter A, Thyroff-Friesinger U, INJ-study group. Therapeutic equivalence, long-term and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol. 2009;72:380–9.
-
(2009)
Clin Nephrol
, vol.72
, pp. 380-389
-
-
Haag-Weber, M.1
Vetter, A.2
Thyroff-Friesinger, U.3
-
32
-
-
84862644490
-
Tungsten-induced denaturation and aggregation of epoetin-alfa during primary packaging as a cause of immunogenicity
-
COI: 1:CAS:528:DC%2BC3MXhsVyktrfJ, PID: 22094831
-
Seidl A, Hainzl O, Richter M, Fischer R, Böhm S, Deutel B, et al. Tungsten-induced denaturation and aggregation of epoetin-alfa during primary packaging as a cause of immunogenicity. Pharm Res. 2012;29:1454–67.
-
(2012)
Pharm Res
, vol.29
, pp. 1454-1467
-
-
Seidl, A.1
Hainzl, O.2
Richter, M.3
Fischer, R.4
Böhm, S.5
Deutel, B.6
-
33
-
-
62549141493
-
Impact of illegal trade on the quality of epoetin alfa in Thailand
-
COI: 1:CAS:528:DC%2BD1MXkvVCqsrw%3D, PID: 19302906
-
Fotiou F, Aravind S, Wang PP, Nerapusee O. Impact of illegal trade on the quality of epoetin alfa in Thailand. Clin Ther. 2009;31:336–46.
-
(2009)
Clin Ther
, vol.31
, pp. 336-346
-
-
Fotiou, F.1
Aravind, S.2
Wang, P.P.3
Nerapusee, O.4
-
34
-
-
84872450786
-
Factor VIII products and inhibitor development in severe hemophilia A
-
COI: 1:CAS:528:DC%2BC3sXhtFykur4%3D, PID: 23323899
-
Gouw S, van der Born J, Ljung R, Escuriola C, Cid AR, Claeyssens-Donadel S, et al. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med. 2013;368:231–9.
-
(2013)
N Engl J Med
, vol.368
, pp. 231-239
-
-
Gouw, S.1
van der Born, J.2
Ljung, R.3
Escuriola, C.4
Cid, A.R.5
Claeyssens-Donadel, S.6
-
35
-
-
84925411090
-
Switching treatments in haemophilia: is there a risk of inhibitor development?
-
PID: 25135593
-
Santagostino E, Auerswald G, Benson G, Dolan G, Jiménez-Yuste V, Lambert T, et al. Switching treatments in haemophilia: is there a risk of inhibitor development? Eur J Haematol. 2015;94:284–9.
-
(2015)
Eur J Haematol
, vol.94
, pp. 284-289
-
-
Santagostino, E.1
Auerswald, G.2
Benson, G.3
Dolan, G.4
Jiménez-Yuste, V.5
Lambert, T.6
-
36
-
-
72749127602
-
Influence of interferon-beta therapy switching on neutralizing antibody titres: results from the Austrian Switch Study
-
COI: 1:CAS:528:DC%2BC3cXhtlaqsrs%3D, PID: 19965519
-
Gneiss C, Koudouovoh-Tripp PM, Ropele S, Gotwald T, Ehling R, Lutterotti A, et al. Influence of interferon-beta therapy switching on neutralizing antibody titres: results from the Austrian Switch Study. Mult Scler. 2009;15:1481–8.
-
(2009)
Mult Scler.
, vol.15
, pp. 1481-1488
-
-
Gneiss, C.1
Koudouovoh-Tripp, P.M.2
Ropele, S.3
Gotwald, T.4
Ehling, R.5
Lutterotti, A.6
-
37
-
-
84982141850
-
-
CHMP assessment report: herceptin subcutaneous formulation. Accessed 30 Sept 2016
-
European Medicines Agency (EMA). CHMP assessment report: herceptin subcutaneous formulation. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000278/WC500153233.pdf. Accessed 30 Sept 2016.
-
(2016)
European Medicines Agency (EMA)
-
-
-
38
-
-
85012255168
-
® to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study
-
PID: 27095751
-
® to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. J Crohns Colitis. 2016;10(11):1287–93. doi:10.1093/ecco-jcc/jjw087.
-
(2016)
J Crohns Colitis.
, vol.10
, Issue.11
, pp. 1287-1293
-
-
Smits, L.J.1
Derikx, L.A.2
de Jong, D.J.3
Boshuizen, R.S.4
van Esch, A.A.5
Drenth, J.P.6
Hoentjen, F.7
-
39
-
-
84979496968
-
-
Benucci M, Gobbi FL, Bandinelli F, Damiani A Infantino M, Grossi V, et al.Immunol Res. 2016. doi: (Epub 23 Jul 2016)
-
Benucci M, Gobbi FL, Bandinelli F, Damiani A Infantino M, Grossi V, et al. Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study. Immunol Res. 2016. doi:10.1007/s12026-016-8843-5 (Epub 23 Jul 2016).
-
(2016)
Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study
-
-
-
40
-
-
85021225235
-
-
® is safe and feasible: a prospective, open-label study.2016. doi: (Epub 22 September 2016).
-
® is safe and feasible: a prospective, open-label study. J Crohns Colitis. 2016. doi:10.1093/ecco-jcc/jjw166 (Epub 22 September 2016).
-
(2016)
J Crohns Colitis
-
-
-
41
-
-
84918518708
-
Switching from originator to biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden
-
PID: 24392303
-
Flodmark C-E, Lilja K, Woehling H, Järvholm K. Switching from originator to biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden. Biol Ther. 2013;3:35–43.
-
(2013)
Biol Ther.
, vol.3
, pp. 35-43
-
-
Flodmark, C.-E.1
Lilja, K.2
Woehling, H.3
Järvholm, K.4
-
42
-
-
84898803216
-
Effect of switching recombinant human growth hormone: comparative analysis of phase 3 clinical data
-
Romer T, Zabransky M, Walczak M, Szalecki M, Balzer S. Effect of switching recombinant human growth hormone: comparative analysis of phase 3 clinical data. Biol Ther. 2011;1:005.
-
(2011)
Biol Ther.
, vol.1
, pp. 005
-
-
Romer, T.1
Zabransky, M.2
Walczak, M.3
Szalecki, M.4
Balzer, S.5
-
43
-
-
84978817333
-
® from other recombinant human growth hormone therapies: retrospective study in an integrated healthcare system
-
PID: 25096555
-
® from other recombinant human growth hormone therapies: retrospective study in an integrated healthcare system. Biol Ther. 2014;4:27–39.
-
(2014)
Biol Ther.
, vol.4
, pp. 27-39
-
-
Rashid, N.1
Saenger, P.2
Wu, Y.L.3
-
44
-
-
84876736657
-
A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia
-
PID: 23052412
-
Hörbrand F, Bramlage P, Fischaleck J, Hasford J, Brunkhorst R. A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia. Eur J Clin Pharmacol. 2013;69:929–36.
-
(2013)
Eur J Clin Pharmacol
, vol.69
, pp. 929-936
-
-
Hörbrand, F.1
Bramlage, P.2
Fischaleck, J.3
Hasford, J.4
Brunkhorst, R.5
-
45
-
-
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
-
PID: 27130908
-
Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, 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(2):355–63. doi:10.1136/annrheumdis-2015-208786.
-
(2017)
Ann Rheum Dis
, vol.76
, Issue.2
, pp. 355-363
-
-
Yoo, D.H.1
Prodanovic, N.2
Jaworski, J.3
Miranda, P.4
Ramiterre, E.5
Lanzon, A.6
-
46
-
-
84901920947
-
A review of CT-P13: an infliximab biosimilar
-
COI: 1:CAS:528:DC%2BC2cXmt1GlsLY%3D, PID: 24723086
-
McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28:313–21.
-
(2014)
BioDrugs.
, vol.28
, pp. 313-321
-
-
McKeage, K.1
-
47
-
-
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, Sokka T. 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(12):1677–83.
-
(2015)
Expert Opin Biol Ther.
, vol.15
, Issue.12
, pp. 1677-1683
-
-
Nikiphorou, E.1
Kautiainen, H.2
Hannonen, P.3
Asikainen, J.4
Kokko, A.5
Rannio, T.6
Sokka, T.7
-
48
-
-
84995578185
-
The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis
-
COI: 1:CAS:528:DC%2BC28Xht1ygsr7O, PID: 27473452
-
Dapavo P, Vujic I, Fierro MT, Pietro Q, Sanlorenzo M. The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75(4):736–9. doi:10.1016/j.jaad.2016.04.068.
-
(2016)
J Am Acad Dermatol
, vol.75
, Issue.4
, pp. 736-739
-
-
Dapavo, P.1
Vujic, I.2
Fierro, M.T.3
Pietro, Q.4
Sanlorenzo, M.5
-
49
-
-
85011663828
-
Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations
-
COI: 1:STN:280:DC%2BC28rmtlOjtw%3D%3D, PID: 26721942
-
Sieczkowska J, Jarzebicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10(2):127–32.
-
(2016)
J Crohns Colitis.
, vol.10
, Issue.2
, pp. 127-132
-
-
Sieczkowska, J.1
Jarzebicka, D.2
Banaszkiewicz, A.3
Plocek, A.4
Gawronska, A.5
Toporowska-Kowalska, E.6
-
50
-
-
84942325078
-
Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea
-
PID: 26395533
-
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):35–44.
-
(2015)
Expert Rev Gastroenterol Hepatol.
, vol.9
, pp. 35-44
-
-
Park, S.H.1
Kim, Y.H.2
Lee, J.H.3
Kwon, H.J.4
Lee, S.H.5
Park, D.I.6
-
53
-
-
85017017931
-
Comparable safety and immunogenicity and sustained efficacy after transition To SB2 (an infliximab biosimilar) vs ongoing infliximab reference product in patients with rheumatoid arthritis: results of phase III transition study (a poster
-
Smolen JS, Choe J-Y, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. (FRI0162) comparable safety and immunogenicity and sustained efficacy after transition To SB2 (an infliximab biosimilar) vs ongoing infliximab reference product in patients with rheumatoid arthritis: results of phase III transition study (a poster. Ann Rheum Dis. 2016;75:488.)
-
(2016)
Ann Rheum Dis
, vol.75
, pp. 488
-
-
Smolen, J.S.1
Choe, J.-Y.2
Prodanovic, N.3
Niebrzydowski, J.4
Staykov, I.5
Dokoupilova, E.6
-
54
-
-
85017000928
-
Meeting materials, arthritis advisory committee. Briefing Information for the July 12–13, 2016
-
US Department of Health and Human Services. US Food and Drug Administration. 2016 Meeting materials, arthritis advisory committee. Briefing Information for the July 12–13, 2016, Meeting of the Arthritis Advisory Committee (AAC). http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/ucm481975.htm. Accessed 30 Dec 2016.
-
(2016)
Meeting of the Arthritis Advisory Committee (AAC
-
-
-
55
-
-
84977763676
-
Biosimilars: terms of use
-
COI: 1:CAS:528:DC%2BC2MXhslyksrnL, PID: 26397731
-
Declerck P, Mellstedt H, Danese S. Biosimilars: terms of use. Curr Med Res Opin. 2015;31:2325–30.
-
(2015)
Curr Med Res Opin
, vol.31
, pp. 2325-2330
-
-
Declerck, P.1
Mellstedt, H.2
Danese, S.3
-
56
-
-
84953403470
-
The constrained prescription interchangeability and substitution of biosimilars
-
COI: 1:CAS:528:DC%2BC2MXht1ensLfI, PID: 26154003
-
Minghetti P, Rocco P, Schellekens H. The constrained prescription interchangeability and substitution of biosimilars. Nat Biotechnol. 2015;33:688–9.
-
(2015)
Nat Biotechnol
, vol.33
, pp. 688-689
-
-
Minghetti, P.1
Rocco, P.2
Schellekens, H.3
-
57
-
-
84881122457
-
Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA adverse event reporting system (FAERS) and EudraVigilance data bases
-
PID: 23771794
-
Vermeer N, Straus S, Mantel-Teeuwisse A, Domergue F, Egberts ACG, Leufkens HGM, de Bruin ML. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA adverse event reporting system (FAERS) and EudraVigilance data bases. Drug Saf. 2013;36:617–25.
-
(2013)
Drug Saf
, vol.36
, pp. 617-625
-
-
Vermeer, N.1
Straus, S.2
Mantel-Teeuwisse, A.3
Domergue, F.4
Egberts, A.C.G.5
Leufkens, H.G.M.6
de Bruin, M.L.7
-
58
-
-
59349100314
-
Initiating insulin therapy with, or switching existing insulin therapy to, insulin aspart 30/70 (Novomix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study
-
COI: 1:CAS:528:DC%2BC3cXksVequ74%3D, PID: 19187170
-
Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, et al. Initiating insulin therapy with, or switching existing insulin therapy to, insulin aspart 30/70 (Novomix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Int J Clin Pract. 2009;63:522–31.
-
(2009)
Int J Clin Pract
, vol.63
, pp. 522-531
-
-
Valensi, P.1
Benroubi, M.2
Borzi, V.3
Gumprecht, J.4
Kawamori, R.5
Shaban, J.6
-
59
-
-
77957025432
-
Switching biologicals for psoriasis
-
PID: 20854399
-
Ormerod AD. Switching biologicals for psoriasis. Br J Dermatol. 2010;163:667–9.
-
(2010)
Br J Dermatol
, vol.163
, pp. 667-669
-
-
Ormerod, A.D.1
-
60
-
-
79751472562
-
The London position statement of the world congress of gastroenterology on biological therapy for IBD with the European Crohn’s and colitis organisation: when to start, when to stop, which drug to choose and how to predict response?
-
PID: 21045814
-
D’Haens GR, Panaccione R, Higgins PD, et al. The London position statement of the world congress of gastroenterology on biological therapy for IBD with the European Crohn’s and colitis organisation: when to start, when to stop, which drug to choose and how to predict response? Am J Gastroenterol. 2011;106:199–212.
-
(2011)
Am J Gastroenterol
, vol.106
, pp. 199-212
-
-
D’Haens, G.R.1
Panaccione, R.2
Higgins, P.D.3
-
61
-
-
84997639519
-
Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016
-
Annese V, Avendaño-Solá C, Breedveld F, Ekman N, Giezen TJ, Gomollón F, et al. Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016. GaBI J. 2016;5(2):74–83.
-
(2016)
GaBI J.
, vol.5
, Issue.2
, pp. 74-83
-
-
Annese, V.1
Avendaño-Solá, C.2
Breedveld, F.3
Ekman, N.4
Giezen, T.J.5
Gomollón, F.6
-
62
-
-
85021327117
-
-
Are biosimilar medicinal products interchangeable?. Accessed 19 Jan 2017
-
Medicines Evaluation Board (MEB). Are biosimilar medicinal products interchangeable? https://english.cbg-meb.nl/latest/news/2015/08/17/clarification-of-stance-on-biological-and-biosimilarmedicines. Accessed 19 Jan 2017.
-
(2017)
Medicines Evaluation Board (MEB)
-
-
-
63
-
-
85016940380
-
-
Are biosimilars interchangeable?. Accessed 19 Jan 2017
-
Finnish Medicines Agency Fimea. Are biosimilars interchangeable? https://www.fimea.fi/documents/542809/838272/29197_Biosimilaarien_vaihtokelpoisuus_EN.pdf. Accessed 19 Jan 2017.
-
(2017)
Finnish Medicines Agency Fimea
-
-
-
64
-
-
85016977720
-
Biosimilar medicines: a national prescribing framework
-
Healthcare Improvement Scotland and NHS. Biosimilar medicines: a national prescribing framework. May 2015. http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/programme_resources/biosimilar_medicines_framework.aspx. Accessed 2 Oct 2016.
-
(2015)
May
-
-
Scotland, H.I.1
-
65
-
-
85016998329
-
Guide to biosimilars for healthcare professionals and patients
-
Health Products Regulatory Agency (Ireland). Guide to biosimilars for healthcare professionals and patients. December 2015. https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-to-biosimilars-for-healthcare-professionals-and-patients-v2.pdf?sfvrsn=18. Accessed 2 Oct 2016.
-
(2015)
December
-
-
-
66
-
-
85013300319
-
-
Update December 2015. Accessed 13 Oct 2016.
-
Position of Paul-Ehrlich-Institute regarding the use of biosimilars. Update December 2015. http://www.pei.de/EN/medicinal-products/antibodies-immunoglobulins-fusion-proteins/monoclonal-antibodies/biosimilars/position-pei-interchangebility-biosimilars-content.html. Accessed 13 Oct 2016.
-
(2015)
Position of Paul-Ehrlich-Institute regarding the use of biosimilars
-
-
|