-
2
-
-
84939517252
-
-
Biologics Price Competition and Innovation Act, BPCI Act SEC. 7002 b
-
Biologics Price Competition and Innovation Act, BPCI Act SEC. 7002 b.
-
-
-
-
4
-
-
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 W1, 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
-
5
-
-
13444253765
-
Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT)
-
van der HEIJDE D, DIJKMANS B, GEUSENS P et al.: Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005; 52: 582-91.
-
(2005)
Arthritis Rheum
, vol.52
, pp. 582-591
-
-
Van Der Heijde, D.1
Dijkmans, B.2
Geusens, P.3
-
6
-
-
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 DHL HRYCAJ P, MIRANDA P 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: 1613-20.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1613-1620
-
-
Yoo, D.H.L.1
Hrycaj, P.2
Miranda, P.3
-
7
-
-
0033524159
-
Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group
-
MAINI R, ST CLAIR EW, BREEDVELD F et al.: Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999; 354: 1932-9.
-
(1999)
Lancet
, vol.354
, pp. 1932-1939
-
-
Maini, R.1
St Clair, E.W.2
Breedveld, F.3
-
8
-
-
33646379583
-
The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial
-
WESTHOVENS R, YOCUM D, HAN J et al.: The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial. Arthritis Rheum 2006; 54: 1075-86.
-
(2006)
Arthritis Rheum
, vol.54
, pp. 1075-1086
-
-
Westhovens, R.1
Yocum, D.2
Han, J.3
-
9
-
-
79955675294
-
Next generation and bio-similar monoclonal antibodies: essential considerations towards regulatory acceptance in Europe. February 3-4, 2011, Freiburg, Germany
-
REICHERT JM: Next generation and bio-similar monoclonal antibodies: essential considerations towards regulatory acceptance in Europe. February 3-4, 2011, Freiburg, Germany. MAbs 2011; 3: 223-40.
-
(2011)
MAbs
, vol.3
, pp. 223-240
-
-
Reichert, J.M.1
-
10
-
-
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: 22-6.
-
(2014)
AAPS J
, vol.16
, pp. 22-26
-
-
Lee, H.1
-
12
-
-
84904063633
-
The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab
-
UNGAR B, CHOWERS Y, YAVZORI M et al.: The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut 2013. doi:10.1136/gutjnl-2013-305259.
-
(2013)
Gut
-
-
Ungar, B.1
Chowers, Y.2
Yavzori, M.3
-
13
-
-
33845882484
-
Biologic therapies in rheumatology: lessons learned, future directions
-
STRAND V, KIMBERLY R, ISAACS JD: Biologic therapies in rheumatology: lessons learned, future directions. Nat Rev Drug Discov 2007; 6: 75-92.
-
(2007)
Nat Rev Drug Discov
, vol.6
, pp. 75-92
-
-
Strand, V.1
Kimberly, R.2
Isaacs, J.D.3
-
14
-
-
79960935860
-
Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis
-
PASCUAL-SALCEDO D, PLASENCIA C, RAMIRO S et al.: Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis; Rheumatology 2011; 50: 1445-52.
-
(2011)
Rheumatology
, vol.50
, pp. 1445-1452
-
-
Pascual-Salcedo, D.1
Plasencia, C.2
Ramiro, S.3
-
15
-
-
84939474933
-
-
Zagreb, 14 June
-
TRUUS JANSE-de HOOG, Staff member MEBmeb: Interchangeability of generics. Zagreb, 14 June 2011.
-
(2011)
Interchangeability of generics
-
-
-
16
-
-
84873635799
-
The role of biosimilars in the treatment of rheumatic diseases
-
DöRNER T, STRAND V, CASTAñEDA-HERNáNDEZ G et al.: The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013; 72: 322-8.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 322-328
-
-
Dörner, T.1
Strand, V.2
Castañeda-Hernández, G.3
-
18
-
-
84870284603
-
Biosimilars in rheumatology: pharmacological and pharmacoeconomic issues
-
LAPADULA G, FERRACCIOLI GF: Biosimilars in rheumatology: pharmacological and pharmacoeconomic issues. Clin Exp Rheumatol 2012; 30: S102-6.
-
(2012)
Clin Exp Rheumatol
, vol.30
, pp. S102-S106
-
-
Lapadula, G.1
Ferraccioli, G.F.2
|