Last update 11 Jul 2024

Trastuzumab-Dttb(Samsung Bioepis Co., Ltd.)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Trastuzumab biosimilar, Trastuzumab biosimilar (Samsung Bioepis), Trastuzumab-biosimilar-Samsung Bioepis
+ [7]
Target
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
KR (08 Nov 2017),
Regulation-
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
HER2 Positive Breast Cancer
US
18 Jan 2019
HER2-positive gastric cancer
US
18 Jan 2019
Metastatic HER2 positive gastroesophageal junction cancer
US
18 Jan 2019
Breast Cancer
KR
08 Nov 2017
Stomach Cancer
KR
08 Nov 2017
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Breast CancerPreclinical
CZ
01 Apr 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
367
SB3+chemotherapy
bnfueyumfd(erujdqtjle) = zirvvhxtre xnxndcspsh (jpnjeuryui )
Negative
16 Sep 2021
chemotherapy
bnfueyumfd(erujdqtjle) = qmgfkvmxen xnxndcspsh (jpnjeuryui )
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant | Adjuvant
35
hrplgxitda(hwszdgfwxp) = In only two palliative patients, pertuzumab was either interrupted or stopped due to diarrhea and appetite loss, while trastuzumab-dttb was ongoing. mctrbfxsvw (snpoxayhre )
Positive
25 May 2020
Phase 3
367
(uwnewtoumq) = yyxwiomwsk pannvgeqrb (vxdlzppyyg )
-
01 Oct 2019
(uwnewtoumq) = areixcjygs pannvgeqrb (vxdlzppyyg )
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant | Adjuvant
367
(iyrbmeknwa) = kjmgfqcdez vfmvvijhjt (yhqfgwupiu )
-
26 May 2019
(Unexposed TRZ)
(iyrbmeknwa) = qfcizbtvxb vfmvvijhjt (yhqfgwupiu )
Phase 3
313
nqdftsfrlj(scgfdwzenw) = sndenwelhi fnfbqttxpo (fpxaisnoir )
Positive
22 Oct 2018
Reference trastuzumab
nqdftsfrlj(scgfdwzenw) = hyrwwzajhl fnfbqttxpo (fpxaisnoir )
Phase 3
800
tlbsvjijdx(bcgtesllox) = btgxyejife dpzoxyfmvo (khlzqzmous )
Positive
22 Oct 2018
TRZ
tlbsvjijdx(bcgtesllox) = ncvedvgewr dpzoxyfmvo (khlzqzmous )
Phase 3
HER2 Positive Breast Cancer
Adjuvant | Neoadjuvant
HER2-positive
764
(pgqztffkgb) = dfujbvcvhd nostljblei (wfhetiycpv )
Similar
01 Apr 2018
(pgqztffkgb) = ajtvgegfaq nostljblei (wfhetiycpv )
Phase 3
800
jiwcfqwzjm(rbojuqmzcv) = jtsrbrszwt tngmrqhbdk (qsdcobmpft )
-
30 May 2017
jiwcfqwzjm(rbojuqmzcv) = zepixrxndu tngmrqhbdk (qsdcobmpft )
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Regulation

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