-
1
-
-
67449138587
-
Biosimilars-science, status, and strategic perspective
-
Kresse GB. Biosimilars-science, status, and strategic perspective. Eur J Pharm Biopharm. 2009;72(3):479-86.
-
(2009)
Eur J Pharm Biopharm
, vol.72
, Issue.3
, pp. 479-486
-
-
Kresse, G.B.1
-
2
-
-
85032470394
-
-
World Health Organization. Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva, 19-23 October, 2009 [homepage on the Internet]. 2010 Apr 6 [cited 2014 May 27]. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
-
-
-
-
3
-
-
77949469515
-
Are biosimilars really generics?
-
Misra A. Are biosimilars really generics? Expert Opin Biol Ther. 2010;10(4):489-94.
-
(2010)
Expert Opin Biol Ther
, vol.10
, Issue.4
, pp. 489-494
-
-
Misra, A.1
-
4
-
-
77953343625
-
Biosmilars: current status and future directions
-
Roger SD. Biosmilars: current status and future directions. Expert Opin Biol Ther. 2010;10(7):1011-8.
-
(2010)
Expert Opin Biol Ther
, vol.10
, Issue.7
, pp. 1011-1018
-
-
Roger, S.D.1
-
5
-
-
47349092310
-
Current legal, regulatory, and scientific implications of biosimilars
-
Wenzel RG. Current legal, regulatory, and scientific implications of biosimilars. Introduction. Am J Health Syst Pharm. 2008;65(14 Suppl 6):S1. doi:10.2146/ajhp080209
-
(2008)
Introduction. Am J Health Syst Pharm
, vol.65
, pp. S1
-
-
Wenzel, R.G.1
-
6
-
-
84896883598
-
Biosimilars: how similar?
-
Mar
-
Strand V, Cronstein B. Biosimilars: how similar? Intern Med J. 2014 Mar;44(3):218-23. doi:10.1111/imj.12292
-
(2014)
Intern Med J
, vol.44
, Issue.3
, pp. 218-223
-
-
Strand, V.1
Cronstein, B.2
-
7
-
-
77955115555
-
Biosimilars and regulatory authorities
-
Minghetti P, Rocco P, Del Vecchio L, Locatelli F. Biosimilars and regulatory authorities. Nephrol Clin Pract. 2011;117(1):c1-7.
-
(2011)
Nephrol Clin Pract
, vol.117
, Issue.1
, pp. c1-7
-
-
Minghetti, P.1
Rocco, P.2
Del Vecchio, L.3
Locatelli, F.4
-
9
-
-
77951028492
-
Biosimilars: controversies as illustrated by rhGH
-
Declerck PJ, Darendeliler F, Góth M, Kolouskova S, Micle I, Noordam C, et al. Biosimilars: controversies as illustrated by rhGH. Curr Med Res Opin. 2010;26(5):1219-29.
-
(2010)
Curr Med Res Opin
, vol.26
, Issue.5
, pp. 1219-1229
-
-
Declerck, P.J.1
Darendeliler, F.2
Góth, M.3
Kolouskova, S.4
Micle, I.5
Noordam, C.6
-
10
-
-
84885412935
-
Saving money in the European healthcare systems with biosimilars
-
Haustein R, de Millas C, Höer A, Häussler B. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4).120-6. doi:10.5639/gabij.2012.0103-4.036
-
(2012)
Generics and Biosimilars Initiative Journal (GaBI Journal)
, vol.1
, Issue.3-4
, pp. 120-126
-
-
Haustein, R.1
de Millas, C.2
Höer, A.3
Häussler, B.4
-
11
-
-
84950998637
-
Biosimilar monoclonal antibodies approved for use in the EU
-
Thorpe R. Biosimilar monoclonal antibodies approved for use in the EU. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(1):9. doi:10.5639/gabij.2014.0301.004
-
(2014)
Generics and Biosimilars Initiative Journal (GaBI Journal)
, vol.3
, Issue.1
, pp. 9
-
-
Thorpe, R.1
-
12
-
-
84864871547
-
In support of the European Union biosmilar framework
-
Scheneider C, Borg J, Ehmann F, Ekman N, Hienonen E, Ho K, et al. In support of the European Union biosmilar framework. Nat Biotech. 2012;30(8):745-8.
-
(2012)
Nat Biotech
, vol.30
, Issue.8
, pp. 745-748
-
-
Scheneider, C.1
Borg, J.2
Ehmann, F.3
Ekman, N.4
Hienonen, E.5
Ho, K.6
-
13
-
-
84855831175
-
The regulatory framework of biosimilars in the European Union
-
Minghetti P, Rocco P, Cilurzo F, Del Vecchio L, Locatelli F. The regulatory framework of biosimilars in the European Union. 2012. Drug Discovery Today. 2012;17(1-2):63-70.
-
(2012)
2012. Drug Discovery Today
, vol.17
, Issue.1-2
, pp. 63-70
-
-
Minghetti, P.1
Rocco, P.2
Cilurzo, F.3
Del Vecchio, L.4
Locatelli, F.5
-
14
-
-
84874472951
-
Biosimilars and market access: a question of comparability and costs?
-
Simoens S, Verbeken G, Huys I. Biosimilars and market access: a question of comparability and costs? Target Oncol. 2012;7(4):227-31.
-
(2012)
Target Oncol
, vol.7
, Issue.4
, pp. 227-231
-
-
Simoens, S.1
Verbeken, G.2
Huys, I.3
-
15
-
-
85032514728
-
-
Shapiro M. Quality Considerations for biosimilars. Federal Drug Administration. Division of Monoclonal Antibodies/OBP/OPS. Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. 8 Aug 2012. Presentation [homepage on the Internet]. 2012 Aug 16 [cited 2014 May 17]. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM315764.pdf
-
-
-
-
16
-
-
85032465735
-
-
European Medical Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the choice of the non-inferiority margin. London, 27 July 2005. Doc. Ref. EMEA/CPMP/EWP/2158/99 [homepage on the Internet]. 2012 Aug 16 [cited 2014 May 17]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003636.pdf
-
-
-
-
17
-
-
45949108207
-
WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19-20 April 2007
-
Joung J, Robertson JS, Griffiths E, Knezevic I. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19-20 April 2007. Biologicals. 2008;36(4):269-76.
-
(2008)
Biologicals
, vol.36
, Issue.4
, pp. 269-276
-
-
Joung, J.1
Robertson, J.S.2
Griffiths, E.3
Knezevic, I.4
-
18
-
-
0034754477
-
Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial
-
Nov
-
Sandborn WJ, Hanauer SB, Katz S, Safdi M, Wolf DG, Baerg RD, et al. Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2001 Nov;121(5):1088-94.
-
(2001)
Gastroenterology
, vol.121
, Issue.5
, pp. 1088-1094
-
-
Sandborn, W.J.1
Hanauer, S.B.2
Katz, S.3
Safdi, M.4
Wolf, D.G.5
Baerg, R.D.6
-
19
-
-
33846242958
-
Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial
-
Jan
-
Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65.
-
(2007)
Gastroenterology
, vol.132
, Issue.1
, pp. 52-65
-
-
Colombel, J.F.1
Sandborn, W.J.2
Rutgeerts, P.3
Enns, R.4
Hanauer, S.B.5
Panaccione, R.6
-
20
-
-
77953701867
-
Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study
-
Jun
-
Keystone E, Genovese MC, Klareskog L, Hsia EC, Hall S, Miranda PC, et al. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study. Ann Rheum Dis. 2010 Jun;69(6):1129-35.
-
(2010)
Ann Rheum Dis
, vol.69
, Issue.6
, pp. 1129-1135
-
-
Keystone, E.1
Genovese, M.C.2
Klareskog, L.3
Hsia, E.C.4
Hall, S.5
Miranda, P.C.6
-
21
-
-
67650379733
-
GO-AFTER study investigators. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial
-
Jul 18
-
Smolen JS, Kay J, Doyle MK, Landewé R, Matteson EL, Wollenhaupt J, et al; GO-AFTER study investigators. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009 Jul 18;374(9685):210-21.
-
(2009)
Lancet
, vol.374
, Issue.9685
, pp. 210-221
-
-
Smolen, J.S.1
Kay, J.2
Doyle, M.K.3
Landewé, R.4
Matteson, E.L.5
Wollenhaupt, J.6
-
22
-
-
68049099274
-
Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis
-
Aug
-
Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, et al. Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009 Aug;60(8):2272-83.
-
(2009)
Arthritis Rheum
, vol.60
, Issue.8
, pp. 2272-2283
-
-
Emery, P.1
Fleischmann, R.M.2
Moreland, L.W.3
Hsia, E.C.4
Strusberg, I.5
Durez, P.6
-
23
-
-
80051984166
-
Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations
-
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
-
24
-
-
85032492210
-
-
European Medical Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London, 22 February 2006. EMEA/CHMP/BMWP/42832/2005 [homepage on the Internet]. 2006 Mar 8 [cited 2014 May 27]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf
-
-
-
-
27
-
-
84887860699
-
Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America
-
Dec
-
Ibarra-Cabrera R, Mena-Pérez SC, Bondani-Guasti A, García-Arrazola R. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America. Biotechnol Adv. 2013 Dec;31(8):1333-43.
-
(2013)
Biotechnol Adv
, vol.31
, Issue.8
, pp. 1333-1343
-
-
Ibarra-Cabrera, R.1
Mena-Pérez, S.C.2
Bondani-Guasti, A.3
García-Arrazola, R.4
-
28
-
-
85032487459
-
-
Kirchlechner T. Current regulations of biosimilars in the Latin American region. 3rd Annual Drug Information Association (DIA) Latin American Regulatory Conference; 12-15 Apr 2011; Panama City, Panama.
-
-
-
-
29
-
-
84860407952
-
Current development in regulation of similar biotherapeutic products in Brazil
-
Castanheira LG, Barbano DB, Rech N. Current development in regulation of similar biotherapeutic products in Brazil. Biologicals. 2011;39(5):308-11.
-
(2011)
Biologicals
, vol.39
, Issue.5
, pp. 308-311
-
-
Castanheira, L.G.1
Barbano, D.B.2
Rech, N.3
-
30
-
-
84867841480
-
Biosimilars in rheumatology: a view from Latin America
-
Mysler E, Scheinberg M. Biosimilars in rheumatology: a view from Latin America. Clin Rheumatol. 2012;31(9):1279-80.
-
(2012)
Clin Rheumatol
, vol.31
, Issue.9
, pp. 1279-1280
-
-
Mysler, E.1
Scheinberg, M.2
-
31
-
-
85032481276
-
-
Dalgaard K, Evers M, Santos da Silva J. Biosimilars seven years on: where are we and what's next? Insights into Pharmaceuticals and Medical Products. February 2013 [homepage on the Internet]. 2013 Feb 12 [cited 2014 May 27]. Available from: http://www.mckinsey.com/~/media/mckinsey/dotcom/client_service/Pharma%20and%20Medical%20Products/PMP%20NEW/PDFs/Biosimilars%20Seven%20years%20on_White%20Paper.ashx
-
-
-
-
32
-
-
85032504672
-
-
Pan American Health Organization. Red PARF Documento Técnico No. 7: Recomendaciones para la Evaluación de Productos Bioterapéuticos Similares (PBS). (Español y portugués). June 2011 [homepage on the Internet]. 2011 Jun 29 [cited 2014 May 27]. Available from: http://www.paho.org/hq./index.php?option=com_docman&task=doc_download&gid=13592&Itemid=&lang=en
-
-
-
-
33
-
-
85032463859
-
-
Saidon P. Level of adoption and implementation of technical document N° 7. VII Conference of the Pan American Network for Drug Regulatory Harmonization; 5-7 September 2013; Ottawa, Canada. [homepage on the Internet]. [cited 2014 May 27]. Available from: http://www.paho.org/hq/index.php?option=com_docman&task=doc_download&gid=22906&Itemid=270&lang=en
-
-
-
-
34
-
-
85032494284
-
-
Knezevic I. WHO Survey on Biotherapeutic Products (focus on clinical issues). VII Conference of the Pan American Network for Drug Regulatory Harmonization. 5-7 September 2013; Ottawa, Canada [homepage on the Internet]. [cited 2014 May 27]. Available from: http://www.paho.org/hq/index.php?option=com_docman&task=doc_download&gid=22904&Itemid=270&lang=en
-
-
-
-
35
-
-
85032489991
-
-
IMS Institute for Health Informatics. The global use of medicines: outlook through 2017. November 2013 [homepage on the Internet]. 2013 Dec 12 [cited 2014 May 27]. Available from: http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Reports/Global_Use_of_Meds_Outlook_2017/IIHI_Global_Use_of_Meds_Report_2013.pdf
-
-
-
-
36
-
-
85032473985
-
-
ISAGS. Health Council [homepage on the Internet]. [cited 2014 May 27]. Available from: http://www.isags-unasul.org/ interna.asp?lang=2&idarea=37
-
-
-
-
37
-
-
85032470082
-
-
SICA. COMISCA en breve [homepage on the Internet]. [cited 2014 May 27]. Available from: http://www.sica.int/comisca/comisca_enbreve.aspx
-
-
-
-
38
-
-
85032478081
-
-
Pan American Health Organization. Regional Platform on Access and Innovation for Health Technologies [homepage on the Internet]. [cited 2014 May 27. Available from: http://prais.paho.org/rscpaho
-
-
-
|