-
1
-
-
84929641433
-
-
ANVISA. [Internet]. Bases Legais e Guias - Coletânea. Resolução - RDC n 55, de 16 de dezembro de 2010
-
ANVISA. [Internet]. Registro de Produtos Biológicos. Bases Legais e Guias - Coletânea. Resolução - RDC n 55, de 16 de dezembro de 2010. Available from: http://portal.anvisa.gov.br/wps/wcm/connect/935aed0048bd2755a7cdaf9a6e94f0d0/ Registro_Produtos_Biologicos_Hemoterapicos_10102011_WEB. pdf?MOD=AJPERES.
-
Registro de Produtos Biológicos.
-
-
-
2
-
-
84876470598
-
Biossimilares necessitam de dados clínicos comparativos cientificamente confiáveis
-
Azevedo VF. Biossimilares necessitam de dados clínicos comparativos cientificamente confiáveis. Rev Bras Reumatol. 2013;53(1):127-31.
-
(2013)
Rev Bras Reumatol.
, vol.53
, Issue.1
, pp. 127-131
-
-
Azevedo, V.F.1
-
3
-
-
84929641434
-
-
Biologics Price Competition and Innovation Act of 2009, H.R. 3590-687, [Accessed 02.09.14]
-
Biologics Price Competition and Innovation Act of 2009, H.R. 3590-687, Licensure of Biological Products as Biosimilar or Interchangeable. [Accessed 02.09.14]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ ucm216146.pdf
-
Licensure of Biological Products as Biosimilar or Interchangeable.
-
-
-
4
-
-
84929628187
-
-
Biosimilar News. [Internet]. Jul 23. [Accessed 2013 Ap 04]
-
Biosimilar News. [Internet]. World's first biosimilar antibody is approved in Korea; 2012 Jul 23. [Accessed 2013 Ap 04]. Available from: http://www.biosimilarnews. com/worlds-first- biosimilar-antibody-is-approved-in-korea
-
(2012)
World's first biosimilar antibody is approved in Korea
-
-
-
5
-
-
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
-
(2011)
Biologicals.
, vol.39
, Issue.5
, pp. 308
-
-
Castanheira, L.G.1
Barbano, D.B.2
Rech, N.3
-
6
-
-
84872099847
-
-
Celltrion Healthcare Co. Ltd. [Internet]. INFLECTRA (infliximab). [cited 2013 Ap 04]
-
Celltrion Healthcare Co. Ltd. [Internet]. INFLECTRA (infliximab). Product Monograph. [cited 2013 Ap 04]. Available from: http://fresenius-kabi.ca/en/ wp-content/uploads/sites/2/2014/04/Remsima_product-monograph.pdf
-
Product Monograph.
-
-
-
7
-
-
84872099847
-
-
Celltrion Healthcare Co. Ltd. [Internet]. REMSIMA (infliximab). [Accessed 2013 Ap 04]
-
Celltrion Healthcare Co. Ltd. [Internet]. REMSIMA (infliximab). Product Monograph. [Accessed 2013 Ap 04]. Available from: http://fresenius-kabi.ca/en/ wp-content/uploads/sites/2/2014/04/Remsima_product-monograph.pdf
-
Product Monograph.
-
-
-
8
-
-
29144519684
-
The effect of etanercept on anti-cyclic citrullinated peptide antibodies and rheumatoid factor in patients with rheumatoid arthritis
-
Chen, HA, Lin, KC, Chen, CH, Liao, HT, Wang, HP, Chang, HN, et al. The effect of etanercept on anti-cyclic citrullinated peptide antibodies and rheumatoid factor in patients with rheumatoid arthritis. Ann Rheum Dis. 2006;65:35-9.
-
(2006)
Ann Rheum Dis.
, vol.65
, pp. 35-39
-
-
Chen, H.A.1
Lin, K.C.2
Chen, C.H.3
Liao, H.T.4
Wang, H.P.5
Chang, H.N.6
-
9
-
-
84929610400
-
Viewpoint: Knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization
-
Danese S, Fiorino G, Michetti P. Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization. J Crohns Colitis. 2014;8(11):1548-50.
-
(2014)
J Crohns Colitis.
, vol.8
, Issue.11
, pp. 1548-1550
-
-
Danese, S.1
Fiorino, G.2
Michetti, P.3
-
10
-
-
84878624235
-
ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)
-
Danese S, Gomollon F. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013;7(7):586e9.
-
(2013)
J Crohns Colitis.
, vol.7
, Issue.7
-
-
Danese, S.1
Gomollon, F.2
-
11
-
-
84997816399
-
Biological and biosimilars: Is similar the same?
-
Decleck PF. Biological and biosimilars: is similar the same? J Crohns Colitis. 2013;8:S427.
-
(2013)
J Crohns Colitis.
, vol.8
-
-
Decleck, P.F.1
-
12
-
-
84885599208
-
Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics
-
Devlin SM, Bressler B, Bernstein CN, Fedorak RN, Bitton A, Singh H, et al. Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics. Can J Gastroenterol. 2013;27(10):567e71.
-
(2013)
Can J Gastroenterol.
, vol.27
, Issue.10
-
-
Devlin, S.M.1
Bressler, B.2
Bernstein, C.N.3
Fedorak, R.N.4
Bitton, A.5
Singh, H.6
-
13
-
-
84929611377
-
-
European Medicines Agency recommends approval of first two monoclonal antibody biosimilars. [Internet]. [Accessed 2013 Ap 04]
-
European Medicines Agency recommends approval of first two monoclonal antibody biosimilars. [Internet]. Recommendation marks extension of biosimilar concept to new product-class. [Accessed 2013 Ap 04]. Available from: http:// www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/06/ WC500144941.pdf
-
Recommendation marks extension of biosimilar concept to new product-class.
-
-
-
15
-
-
84873083214
-
-
[Internet]. 2012 Nov 14. [Accessed 2013 Ap 04]
-
European Medicines Agency. [Internet]. Biosimilar medicines. 2012. 2012 Nov 14. [Accessed 2013 Ap 04]. Available from: http://www.ema.europa.eu/ema/index. jsp?curl=pages/regulation/general/general_content_000408.jsp
-
(2012)
Biosimilar medicines.
-
-
European Medicines Agency1
-
17
-
-
78049362302
-
-
[Internet]. [Accessed 2014 Ap 02]
-
Expert Committee on Biological Standardization, World Health Organization. [Internet]. Guidelines on evaluation of similar biotherapeutic products. [Accessed 2014 Ap 02]. Available from: http://www.who. int/biologicals/areas/biological_therapeutics/ BIOTHERAPEUTICS_FOR_WEB_ 22APRIL2010.pdf; 2009
-
(2009)
Guidelines on evaluation of similar biotherapeutic products.
-
-
-
18
-
-
84904069611
-
The challenge of indication extrapolation for infliximab biosimilars
-
Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177-83.
-
(2014)
Biologicals.
, vol.42
, Issue.4
, pp. 177-183
-
-
Feagan, B.G.1
Choquette, D.2
Ghosh, S.3
Gladman, D.D.4
Ho, V.5
Meibohm, B.6
-
19
-
-
84876938678
-
Biosimilars in IBD: Hope or expectation?
-
Gecse KB, Khanna R, van den Brink GR, Ponsioen CT, Löwenberg M, Jairath V, Travis SPL, Sandborn WJ, Feagan BG, D'Haens GRAM. Biosimilars in IBD: hope or expectation? Gut. 2013;62(6):803-7.
-
(2013)
Gut.
, vol.62
, Issue.6
, pp. 803-807
-
-
Gecse, K.B.1
Khanna, R.2
van den Brink, G.R.3
Ponsioen, C.T.4
Löwenberg, M.5
Jairath, V.6
Travis, S.P.L.7
Sandborn, W.J.8
Feagan, B.G.9
D'Haens, G.R.A.M.10
-
20
-
-
84885677423
-
Subsequent entry biologics e opportunities and challenges
-
Ghosh S. Subsequent entry biologics e opportunities and challenges. Can J Gastroenterol. 2013;27(10):565.
-
(2013)
Can J Gastroenterol.
, vol.27
, Issue.10
, pp. 565
-
-
Ghosh, S.1
-
21
-
-
34249651994
-
Neutralization of soluble and membrane tumor necrosis factor-alpha (TNF- alpha) by infliximab, adalimumab, or certolizumab pegol using P55 or P75 TNF-alpha receptor- specific bioassays
-
Gramlick A, Fossati G, Nesbitt AM. Neutralization of soluble and membrane tumor necrosis factor-alpha (TNF- alpha) by infliximab, adalimumab, or certolizumab pegol using P55 or P75 TNF-alpha receptor- specific bioassays. Gastroenterology. 2006;130(4):A697.
-
(2006)
Gastroenterology.
, vol.130
, Issue.4
-
-
Gramlick, A.1
Fossati, G.2
Nesbitt, A.M.3
-
24
-
-
79953276605
-
-
Health Products and Food Branch, Health Canada. [Internet]. [Accessed 2014 Sept 27]
-
Health Products and Food Branch, Health Canada. [Internet]. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs). [Accessed 2014 Sept 27]. Available from: http://www.hc-sc.gc.ca/dhp-mps/ alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf; 2010.
-
(2010)
Guidance for sponsors: Information and submission requirements for subsequent entry biologics (SEBs).
-
-
-
25
-
-
84929617140
-
-
Janssen Biologics B.V. [Internet]. [Accessed 2014 Feb 01]
-
Janssen Biologics B.V. [Internet]. REMICADE (infliximab) summary of product characteristics. 2013. [Accessed 2014 Feb 01]. Available from: http://www. ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/ human/000240/WC500050888.pdf.
-
(2013)
REMICADE (infliximab) summary of product characteristics.
-
-
-
27
-
-
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. 2013;16:22e6.
-
(2013)
AAPS J.
, vol.16
-
-
Lee, H.1
-
28
-
-
84855172814
-
The pathogenesis of rheumatoid arthritis
-
McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011;365(23):2205-19.
-
(2011)
N Engl J Med.
, vol.365
, Issue.23
, pp. 2205-2219
-
-
McInnes, I.B.1
Schett, G.2
-
29
-
-
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. 2013;72(10):1605-12.
-
(2013)
Ann Rheum Dis.
, vol.72
, Issue.10
, pp. 1605-1612
-
-
Park, W.1
Hrycaj, P.2
Jeka, S.3
Kovalenko, V.4
Lysenko, G.5
Miranda, P.6
-
30
-
-
84901507530
-
Biosimilars in Crohn's disease
-
Scheinberg M. Biosimilars in Crohn's disease. J Crohns Colitis. 2014;8(7):71.
-
(2014)
J Crohns Colitis.
, vol.8
, Issue.7
, pp. 71
-
-
Scheinberg, M.1
-
31
-
-
38549176118
-
Tumor necrosis factor antagonist mechanisms of action: A comprehensive review
-
Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008;117:244-79.
-
(2008)
Pharmacol Ther.
, vol.117
, pp. 244-279
-
-
Tracey, D.1
Klareskog, L.2
Sasso, E.H.3
Salfeld, J.G.4
Tak, P.P.5
-
32
-
-
84878536093
-
Development and regulation of bio- similars: Current status and future challenges
-
Tsiftsoglou AS, Ruiz S, Schneider CK. Development and regulation of bio- similars: current status and future challenges. BioDrugs. 2013;27(3):203e11.
-
(2013)
BioDrugs.
, vol.27
, Issue.3
-
-
Tsiftsoglou, A.S.1
Ruiz, S.2
Schneider, C.K.3
-
33
-
-
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, 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. 2013;72(10):1613-20.
-
(2013)
Ann Rheum Dis.
, vol.72
, Issue.10
, pp. 1613-1620
-
-
Yoo, D.H.1
Hrycaj, P.2
Miranda, P.3
Ramiterre, E.4
Piotrowski, M.5
Shevchuk, S.6
|