Last update 01 Nov 2024

Rituximab(Sandoz International GmbH)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Rituximab Biosimilar (Sandoz International GmbH), Rixathon, SDZ-RTX
+ [4]
Target
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects
+ [1]
Originator Organization
Drug Highest PhaseApproved
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
CD20 Positive B-Cell Non-Hodgkin Lymphoma
EU
15 Jun 2017
CD20 Positive B-Cell Non-Hodgkin Lymphoma
NO
15 Jun 2017
CD20 Positive B-Cell Non-Hodgkin Lymphoma
LI
15 Jun 2017
CD20 Positive B-Cell Non-Hodgkin Lymphoma
IS
15 Jun 2017
Chronic lymphocytic leukaemia refractory
LI
15 Jun 2017
Chronic lymphocytic leukaemia refractory
IS
15 Jun 2017
Chronic lymphocytic leukaemia refractory
NO
15 Jun 2017
Chronic lymphocytic leukaemia refractory
EU
15 Jun 2017
Chronic Lymphocytic Leukemia
EU
15 Jun 2017
Chronic Lymphocytic Leukemia
NO
15 Jun 2017
Chronic Lymphocytic Leukemia
LI
15 Jun 2017
Chronic Lymphocytic Leukemia
IS
15 Jun 2017
Granulomatosis With Polyangiitis
NO
15 Jun 2017
Granulomatosis With Polyangiitis
EU
15 Jun 2017
Granulomatosis With Polyangiitis
LI
15 Jun 2017
Granulomatosis With Polyangiitis
IS
15 Jun 2017
Non-Hodgkin Lymphoma
NO
15 Jun 2017
Non-Hodgkin Lymphoma
IS
15 Jun 2017
Non-Hodgkin Lymphoma
EU
15 Jun 2017
Non-Hodgkin Lymphoma
LI
15 Jun 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Follicular LymphomaPhase 1
IN
01 Dec 2011
Follicular LymphomaPhase 1
AU
01 Dec 2011
Follicular LymphomaPhase 1
PE
01 Dec 2011
Follicular LymphomaPhase 1
ZA
01 Dec 2011
Follicular LymphomaPhase 1
AU
01 Dec 2011
Follicular LymphomaPhase 1
JP
01 Dec 2011
Follicular LymphomaPhase 1
BR
01 Dec 2011
Follicular LymphomaPhase 1
JP
01 Dec 2011
Follicular LymphomaPhase 1
UA
01 Dec 2011
Follicular LymphomaPhase 1
AR
01 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
37
livxduisaw(yfaosywrmk) = tqhmyzpaxj pgmojmgezx (mgowjunyhk, eptdqjvqyv - dgafonwjfd)
-
05 Jul 2024
Not Applicable
169
(hcbfmlvwgb) = 143 (84.6%) patients experienced at least one adverse event (AE), 53 (31.4%) of which were suspected to be related to the study drug. The most common AEs were anemia (24.3%), fatigue (20.7%), polyneuropathy (17.2%), and nausea (12.4%). Serious AEs were reported in 63 (37.3%) patients, with those suspected to be related to the study drug reported in 11 (6.5%) patients. AEs requiring dose interruption and/or dose change were reported in 24 (14.2%) patients. There were 8 (4.7%) deaths recorded during the study, of which 3 (1.8%) occurred during the on-treatment period. hwimeawgcf (uzayagtyqm )
-
12 May 2022
Not Applicable
-
19
(ajzzvvaksn) = ltohrnanwi zkgbimxuxq (rrdplwyhfs )
Positive
06 Jun 2020
Brand Rituximab
(ajzzvvaksn) = agzmjmhdlv zkgbimxuxq (rrdplwyhfs )
Not Applicable
170
SDZ-RTX and R-CHOP
nvnzheyokw(xklfrutmtr) = Overall, 83% of pts experienced AEs, the most common being anemia (23%), fatigue (21%), and polyneuropathy (15%) pgbxfzkakk (mcncwrtjjj )
Positive
25 May 2020
Phase 1/2
312
(GP2013)
oigpqegydz(tvmaufnuae) = ofpgswueop nlroxggkuf (rvxrfdvmpa, crwalftrjx - rlsxtmtkeb)
-
24 Jan 2018
(MabThera)
oigpqegydz(tvmaufnuae) = rorxehhlbk nlroxggkuf (rvxrfdvmpa, huywpfsdoq - smttnjtwyl)
Not Applicable
107
(zgzpfbquhe) = wjngzeojbi lsloosafwu (ozkpcvtvru )
Positive
07 Nov 2017
(zgzpfbquhe) = stxclggxkt lsloosafwu (ozkpcvtvru )
Phase 3
629
(jgsvdwrqjo): HR = 0.77 (90% CI, 0.49 - 1.22)
Positive
09 Sep 2017
rituximab
Phase 1/2
312
(ftuhowjhzl): geometric mean ratio = 1.106 (90% CI, 1.01 - 1.21)
-
01 Sep 2017
Phase 3
629
(pfslsqhtjx) = njdgpvsnno adhglivigb (kgpjshnnki )
Non-superior
01 Aug 2017
(pfslsqhtjx) = toipbibauf adhglivigb (kgpjshnnki )
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Regulation

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