-
1
-
-
84900432086
-
-
Waltham, Academic Press
-
Plitnick LM, Herzyk DJ: Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. Waltham, Academic Press, 2013.
-
(2013)
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
-
-
Plitnick, L.M.1
Herzyk, D.J.2
-
2
-
-
84904460389
-
Future directions in inflammatory bowel disease management
-
D'Haens GR, Sartor RB, Silverberg MS, Petersson J, Rutgeerts P: Future directions in inflammatory bowel disease management. J Crohns Colitis 2014; 8: 726-734.
-
(2014)
J Crohns Colitis
, vol.8
, pp. 726-734
-
-
D'Haens, G.R.1
Sartor, R.B.2
Silverberg, M.S.3
Petersson, J.4
Rutgeerts, P.5
-
3
-
-
84876938678
-
Biosimilars in ibd: Hope or expectation?
-
Gecse KB, Khanna R, van den Brink GR, Ponsioen CY, Lowenberg M, Jairath V, et al: Biosimilars in IBD: hope or expectation? Gut 2013; 62: 803-807.
-
(2013)
Gut
, vol.62
, pp. 803-807
-
-
Gecse, K.B.1
Khanna, R.2
Van Den Brink, G.R.3
Ponsioen, C.Y.4
Lowenberg, M.5
Jairath, V.6
-
4
-
-
79961203419
-
Biosimilars - Why terminology matters
-
Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, et al: Biosimilars - why terminology matters. Nat Biotechnol 2011; 29: 690-693.
-
(2011)
Nat Biotechnol
, vol.29
, pp. 690-693
-
-
Weise, M.1
Bielsky, M.C.2
De Smet, K.3
Ehmann, F.4
Ekman, N.5
Narayanan, G.6
-
5
-
-
77951529848
-
Therapeutic antibodies for autoimmunity and inflammation
-
Chan AC, Carter PJ: Therapeutic antibodies for autoimmunity and inflammation. Nat Rev Immunol 2010; 10: 301-316.
-
(2010)
Nat Rev Immunol
, vol.10
, pp. 301-316
-
-
Chan, A.C.1
Carter, P.J.2
-
6
-
-
84897377081
-
Biosimilars: In support of extrapolation of indications
-
Ebbers HC: Biosimilars: in support of extrapolation of indications. J Crohns Colitis 2014; 8: 431-435.
-
(2014)
J Crohns Colitis
, vol.8
, pp. 431-435
-
-
Ebbers, H.C.1
-
7
-
-
84863218474
-
Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars
-
Berkowitz SA, Engen JR, Mazzeo JR, Jones GB: Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov 2012; 11: 527-540.
-
(2012)
Nat Rev Drug Discov
, vol.11
, pp. 527-540
-
-
Berkowitz, S.A.1
Engen, J.R.2
Mazzeo, J.R.3
Jones, G.B.4
-
8
-
-
84871157556
-
Generics, chemisimilars and biosimilars: Is clinical testing fit for purpose?
-
Warren JB: Generics, chemisimilars and biosimilars: is clinical testing fit for purpose? Br J Clin Pharmacol 2013; 75: 7-14.
-
(2013)
Br J Clin Pharmacol
, vol.75
, pp. 7-14
-
-
Warren, J.B.1
-
9
-
-
84900459730
-
Biosimilars in the therapy of inflammatory bowel diseases
-
Hlavaty T, Letkovsky J: Biosimilars in the therapy of inflammatory bowel diseases. Eur J Gastroenterol Hepatol 2014; 26: 581-587.
-
(2014)
Eur J Gastroenterol Hepatol
, vol.26
, pp. 581-587
-
-
Hlavaty, T.1
Letkovsky, J.2
-
10
-
-
84884910025
-
Review article: Biosimilars are the next generation of drugs for liver and gastrointestinal diseases
-
Rinaudo-Gaujous M, Paul S, Tedesco ED, Genin C, Roblin X, Peyrin-Biroulet L: Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther 2013; 38: 914-924.
-
(2013)
Aliment Pharmacol Ther
, vol.38
, pp. 914-924
-
-
Rinaudo-Gaujous, M.1
Paul, S.2
Tedesco, E.D.3
Genin, C.4
Roblin, X.5
Peyrin-Biroulet, L.6
-
11
-
-
84896547976
-
Putting the value into biosimilar decision making: The judgment value criteria
-
Mendes de Abreu M, Strand V, Levy RA, Araujo DV: Putting the value into biosimilar decision making: the judgment value criteria. Autoimmun Rev 2014; 13: 678-684.
-
(2014)
Autoimmun Rev
, vol.13
, pp. 678-684
-
-
Mendes De Abreu, M.1
Strand, V.2
Levy, R.A.3
Araujo, D.V.4
-
12
-
-
84876923808
-
Innovation and competition: Will biosimilars succeed? the creation of an fda approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. but so are efficacy and patient safety
-
Blackstone EA, Fuhr JP Jr: Innovation and competition: will biosimilars succeed? The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety. Biotechnol Healthc 2012; 9: 24-27.
-
(2012)
Biotechnol Healthc
, vol.9
, pp. 24-27
-
-
Blackstone, E.A.1
Fuhr, J.P.2
-
13
-
-
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: 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
-
14
-
-
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: 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
-
15
-
-
84898853424
-
The use of biosimilars in immune-mediated disease: A joint italian society of rheumatology (sir), italian society of dermatology (sidemast), and italian group of inflammatory bowel disease (ig-ibd) position paper
-
Fiorino G, Girolomoni G, Lapadula G, Orlando A, Danese S, Olivieri I, et al: The use of biosimilars in immune-mediated disease: a joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev 2014; 13: 751-755.
-
(2014)
Autoimmun Rev
, vol.13
, pp. 751-755
-
-
Fiorino, G.1
Girolomoni, G.2
Lapadula, G.3
Orlando, A.4
Danese, S.5
Olivieri, I.6
-
16
-
-
84894232162
-
EMA response to ecco position statement on biosimilars
-
Danese S, Gomollon F, Michetti P: EMA response to ECCO position statement on biosimilars. J Crohns Colitis 2014; 8: 259.
-
(2014)
J Crohns Colitis
, vol.8
, pp. 259
-
-
Danese, S.1
Gomollon, F.2
Michetti, P.3
-
17
-
-
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 2014; 16: 22-26.
-
(2014)
AAPS J
, vol.16
, pp. 22-26
-
-
Lee, H.1
-
18
-
-
84858793037
-
Anti-tnf monoclonal antibodies in inflammatory bowel disease: Pharmacokinetics- based dosing paradigms
-
Ordas I, Mould DR, Feagan BG, Sandborn WJ: Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics- based dosing paradigms. Clin Pharmacol Ther 2012; 91: 635-646.
-
(2012)
Clin Pharmacol Ther
, vol.91
, pp. 635-646
-
-
Ordas, I.1
Mould, D.R.2
Feagan, B.G.3
Sandborn, W.J.4
-
19
-
-
84896860472
-
EU's new pharmacovigilance legislation: Considerations for biosimilars
-
Calvo B, Zuniga L: EU's new pharmacovigilance legislation: considerations for biosimilars. Drug Saf 2014; 37: 9-18.
-
(2014)
Drug Saf
, vol.37
, pp. 9-18
-
-
Calvo, B.1
Zuniga, L.2
-
21
-
-
84870933584
-
Interchangeability, immunogenicity and biosimilars
-
Ebbers HC, Crow SA, Vulto AG, Schellekens H: Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 2012; 30: 1186-1190.
-
(2012)
Nat Biotechnol
, vol.30
, pp. 1186-1190
-
-
Ebbers, H.C.1
Crow, S.A.2
Vulto, A.G.3
Schellekens, H.4
-
22
-
-
84873635799
-
The role of biosimilars in the treatment of rheumatic diseases
-
Dorner T, Strand V, Castaneda-Hernandez G, Ferraccioli G, Isaacs JD, Kvien TK, et al: The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013; 72: 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
-
23
-
-
84871492817
-
Biosimilars: What clinicians should know
-
Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al: Biosimilars: what clinicians should know. Blood 2012; 120: 5111-5117.
-
(2012)
Blood
, vol.120
, pp. 5111-5117
-
-
Weise, M.1
Bielsky, M.C.2
De Smet, K.3
Ehmann, F.4
Ekman, N.5
Giezen, T.J.6
-
24
-
-
77951586447
-
Strategies and challenges for the next generation of therapeutic antibodies
-
Beck A, Wurch T, Bailly C, Corvaia N: Strategies and challenges for the next generation of therapeutic antibodies. Nat Rev Immunol 2010; 10: 345-352.
-
(2010)
Nat Rev Immunol
, vol.10
, pp. 345-352
-
-
Beck, A.1
Wurch, T.2
Bailly, C.3
Corvaia, N.4
-
25
-
-
84890107812
-
Erythropoietin derived by chemical synthesis
-
Wang P, Dong S, Shieh JH, Peguero E, Hendrickson R, Moore MA, et al: Erythropoietin derived by chemical synthesis. Science 2013; 342: 1357-1360.
-
(2013)
Science
, vol.342
, pp. 1357-1360
-
-
Wang, P.1
Dong, S.2
Shieh, J.H.3
Peguero, E.4
Hendrickson, R.5
Moore, M.A.6
-
26
-
-
84890081659
-
Chemistry. Improving biologic drugs via total chemical synthesis
-
Hsieh-Wilson LC, Griffin ME: Chemistry. Improving biologic drugs via total chemical synthesis. Science 2013; 342: 1332-1333.
-
(2013)
Science
, vol.342
, pp. 1332-1333
-
-
Hsieh-Wilson, L.C.1
Griffin, M.E.2
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