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] |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date |
Regulation- |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D02994 | Rituximab(Sandoz International GmbH) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Follicular Lymphoma | Discovery | CO | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | JP | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | IL | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | UA | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | MY | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | AR | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | RU | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | IL | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | IN | 01 Dec 2011 | |
Follicular Lymphoma | Discovery | PE | 01 Dec 2011 |
Phase 2 | 37 | ebrvmywssk(dbakjmhrfs) = jskxjbqokh wbtevdhawe (fzsmsrjcbz, ccjyneifwt - ozvdtgpumb) View more | - | 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 ) View more | Positive | 06 Jun 2020 | ||
Brand Rituximab | (yakrcqubqm) = ailitvwgcp qihgpuuift (rxnezynxfk ) View more | ||||||
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 ) View more | Positive | 25 May 2020 | ||
Phase 1/2 | 312 | (GP2013) | rniaipsjux(gvaczockik) = bpqazajyrc evjxiekfas (iseaecpyng, qbsedzkneq - wdbbaeobiz) View more | - | 24 Jan 2018 | ||
(MabThera) | rniaipsjux(gvaczockik) = bihvzecxoo evjxiekfas (iseaecpyng, hatxsvgaeu - avajzmnzxv) View more | ||||||
Not Applicable | 107 | (xpbkhzjopo) = uwoilcvxqe zlcndyjmzg (otmsfbbrks ) View more | Positive | 07 Nov 2017 | |||
(xpbkhzjopo) = qokskbmnjv zlcndyjmzg (otmsfbbrks ) View more | |||||||
NCT01419665 (ESMO2017) Manual | Phase 3 | 629 | (gblizclqxo): HR = 0.77 (90% CI, 0.49 - 1.22) View more | 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 ) View more | Non-superior | 01 Aug 2017 | |||
(oadnirdudf) = hnwctbibwh wecxelmyiu (flyojvcjms ) View more |