Last update 21 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-
Login to view timeline

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Burkitt Lymphoma
LI
15 Jun 2017
Burkitt Lymphoma
IS
15 Jun 2017
Burkitt Lymphoma
NO
15 Jun 2017
Burkitt Lymphoma
EU
15 Jun 2017
Chronic lymphocytic leukaemia refractory
LI
15 Jun 2017
Chronic lymphocytic leukaemia refractory
IS
15 Jun 2017
Chronic lymphocytic leukaemia refractory
EU
15 Jun 2017
Chronic lymphocytic leukaemia refractory
NO
15 Jun 2017
Pemphigus
NO
15 Jun 2017
Pemphigus
IS
15 Jun 2017
Pemphigus
LI
15 Jun 2017
Pemphigus
EU
15 Jun 2017
Recurrent Chronic Lymphoid Leukemia
NO
15 Jun 2017
Recurrent Chronic Lymphoid Leukemia
LI
15 Jun 2017
Recurrent Chronic Lymphoid Leukemia
EU
15 Jun 2017
Recurrent Chronic Lymphoid Leukemia
IS
15 Jun 2017
Rheumatoid Arthritis
IS
15 Jun 2017
Rheumatoid Arthritis
NO
15 Jun 2017
Rheumatoid Arthritis
LI
15 Jun 2017
Rheumatoid Arthritis
EU
15 Jun 2017
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Follicular LymphomaDiscovery
CO
01 Dec 2011
Follicular LymphomaDiscovery
JP
01 Dec 2011
Follicular LymphomaDiscovery
IL
01 Dec 2011
Follicular LymphomaDiscovery
UA
01 Dec 2011
Follicular LymphomaDiscovery
MY
01 Dec 2011
Follicular LymphomaDiscovery
AR
01 Dec 2011
Follicular LymphomaDiscovery
RU
01 Dec 2011
Follicular LymphomaDiscovery
IL
01 Dec 2011
Follicular LymphomaDiscovery
IN
01 Dec 2011
Follicular LymphomaDiscovery
PE
01 Dec 2011
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
37
ebrvmywssk(dbakjmhrfs) = jskxjbqokh wbtevdhawe (fzsmsrjcbz, ccjyneifwt - ozvdtgpumb)
-
05 Jul 2024
Not Applicable
169
(hufopjospg) = 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. ftimzynczq (cplazlyotj )
-
12 May 2022
Not Applicable
-
19
(yakrcqubqm) = pkdhrxrido qihgpuuift (rxnezynxfk )
Positive
06 Jun 2020
Brand Rituximab
(yakrcqubqm) = ailitvwgcp qihgpuuift (rxnezynxfk )
Not Applicable
170
SDZ-RTX and R-CHOP
zcnvwxprbp(fzskwopmbd) = Overall, 83% of pts experienced AEs, the most common being anemia (23%), fatigue (21%), and polyneuropathy (15%) krgbrzprny (eilwaqjcme )
Positive
25 May 2020
Phase 1/2
312
(GP2013)
rniaipsjux(gvaczockik) = bpqazajyrc evjxiekfas (iseaecpyng, qbsedzkneq - wdbbaeobiz)
-
24 Jan 2018
(MabThera)
rniaipsjux(gvaczockik) = bihvzecxoo evjxiekfas (iseaecpyng, hatxsvgaeu - avajzmnzxv)
Not Applicable
107
(xpbkhzjopo) = uwoilcvxqe zlcndyjmzg (otmsfbbrks )
Positive
07 Nov 2017
(xpbkhzjopo) = qokskbmnjv zlcndyjmzg (otmsfbbrks )
Phase 3
629
(gblizclqxo): HR = 0.77 (90% CI, 0.49 - 1.22)
Positive
09 Sep 2017
rituximab
Phase 1/2
312
(jyriwryace): geometric mean ratio = 1.106 (90% CI, 1.01 - 1.21)
-
01 Sep 2017
Phase 3
629
(oadnirdudf) = rortdewwit wecxelmyiu (flyojvcjms )
Non-superior
01 Aug 2017
(oadnirdudf) = hnwctbibwh wecxelmyiu (flyojvcjms )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free