Last update 25 Mar 2025

Rituximab(Sandoz International GmbH)

Overview

Basic Info

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

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lupus Nephritis
Japan
27 Sep 2023
Thrombotic Thrombocytopenic Purpura, Acquired
Japan
18 Nov 2020
Chronic idiopathic thrombocytopenic purpura
Japan
02 Sep 2020
CD20 positive Follicular Lymphoma
Australia
30 Nov 2017
Low Grade B-Cell Non-Hodgkin's Lymphoma
Australia
30 Nov 2017
Burkitt Lymphoma
European Union
15 Jun 2017
Burkitt Lymphoma
Iceland
15 Jun 2017
Burkitt Lymphoma
Liechtenstein
15 Jun 2017
Burkitt Lymphoma
Norway
15 Jun 2017
CD20 Positive B-Cell Non-Hodgkin Lymphoma
European Union
15 Jun 2017
CD20 Positive B-Cell Non-Hodgkin Lymphoma
Iceland
15 Jun 2017
CD20 Positive B-Cell Non-Hodgkin Lymphoma
Liechtenstein
15 Jun 2017
CD20 Positive B-Cell Non-Hodgkin Lymphoma
Norway
15 Jun 2017
CD20 positive Diffuse Large B-Cell Lymphoma
European Union
15 Jun 2017
CD20 positive Diffuse Large B-Cell Lymphoma
Iceland
15 Jun 2017
CD20 positive Diffuse Large B-Cell Lymphoma
Liechtenstein
15 Jun 2017
CD20 positive Diffuse Large B-Cell Lymphoma
Norway
15 Jun 2017
Chronic lymphocytic leukaemia refractory
European Union
15 Jun 2017
Chronic lymphocytic leukaemia refractory
Iceland
15 Jun 2017
Chronic lymphocytic leukaemia refractory
Liechtenstein
15 Jun 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Indolent B-Cell Non-Hodgkin LymphomaPhase 1
Japan
01 May 2013
Indolent B-Cell Non-Hodgkin LymphomaPhase 1
Japan
01 May 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
110
Biosimilar Rituximab GP2013
ukarfflgdj(itwprwymmv) = hcjmkrctvx duxyhqqxza (wbaymferuk )
-
31 May 2023
Not Applicable
Multiple Sclerosis
CD-20 monoclonals
29
Riximyo-treated MS patients
hssrslahjo(mnntabovht) = no infection reported in the follow-up period edlogupxov (ygvquxxgak )
Positive
30 May 2023
Not Applicable
169
axsyzcpvxp(ubwrbnngft) = 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. yvfuceqsyz (wxmcgzurrg )
-
12 May 2022
Not Applicable
-
19
jzsgynlfqx(dydbkimthx) = dzebwdafju dbgayehzwy (dhmaolsdsw )
Positive
06 Jun 2020
Brand Rituximab
jzsgynlfqx(dydbkimthx) = vtcfbbctih dbgayehzwy (dhmaolsdsw )
Not Applicable
170
SDZ-RTX and R-CHOP
uhepcbqyoz(zgnsozwtqq) = Overall, 83% of pts experienced AEs, the most common being anemia (23%), fatigue (21%), and polyneuropathy (15%) erwqgdrgvs (lkgpsnvyem )
Positive
25 May 2020
Phase 1/2
312
(GP2013)
cxgnrlfkbu(ppfhnmeavj) = vxvahnxtpa bgsjqcmzwp (qvnfhbmadv, 38.60)
-
24 Jan 2018
(MabThera)
cxgnrlfkbu(ppfhnmeavj) = omaxpcftep bgsjqcmzwp (qvnfhbmadv, 40.56)
Not Applicable
107
vanbcqruhv(ceczyrszrc) = sbkvqdcxql ywmbyuobdr (flsyamdouv )
Positive
07 Nov 2017
vanbcqruhv(ceczyrszrc) = ltxrtfzrbx ywmbyuobdr (flsyamdouv )
Phase 3
629
hgnfqsqvvl(zjykzonjfm): HR = 0.77 (90% CI, 0.49 - 1.22)
Positive
09 Sep 2017
rituximab
Phase 3
629
uezfgavgly(fyanpfhfej) = xafujaituk pjkiumqryq (gvzhohbsvf )
Non-superior
01 Aug 2017
uezfgavgly(fyanpfhfej) = kukieovpax pjkiumqryq (gvzhohbsvf )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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