Last update 28 Aug 2025

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

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
trastuzumab, Trastuzumab biosimilar, Trastuzumab biosimilar (Samsung Bioepis)
+ [7]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
South Korea (08 Nov 2017),
Regulation-
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Structure/Sequence

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2-positive gastric cancer
United States
18 Jan 2019
HER2 positive Gastrooesophageal junction cancer
Australia
09 Jan 2019
HER2 Positive Breast Cancer
European Union
15 Nov 2017
HER2 Positive Breast Cancer
Iceland
15 Nov 2017
HER2 Positive Breast Cancer
Liechtenstein
15 Nov 2017
HER2 Positive Breast Cancer
Norway
15 Nov 2017
HER2 Positive Stomach Adenocarcinoma
European Union
15 Nov 2017
HER2 Positive Stomach Adenocarcinoma
Iceland
15 Nov 2017
HER2 Positive Stomach Adenocarcinoma
Liechtenstein
15 Nov 2017
HER2 Positive Stomach Adenocarcinoma
Norway
15 Nov 2017
Hormone Receptor Positive Breast Adenocarcinoma
European Union
15 Nov 2017
Hormone Receptor Positive Breast Adenocarcinoma
Iceland
15 Nov 2017
Hormone Receptor Positive Breast Adenocarcinoma
Liechtenstein
15 Nov 2017
Hormone Receptor Positive Breast Adenocarcinoma
Norway
15 Nov 2017
Metastatic HER2 positive gastroesophageal junction cancer
European Union
15 Nov 2017
Metastatic HER2 positive gastroesophageal junction cancer
Iceland
15 Nov 2017
Metastatic HER2 positive gastroesophageal junction cancer
Liechtenstein
15 Nov 2017
Metastatic HER2 positive gastroesophageal junction cancer
Norway
15 Nov 2017
Metastatic human epidermal growth factor 2 positive carcinoma of breast
European Union
15 Nov 2017
Metastatic human epidermal growth factor 2 positive carcinoma of breast
Iceland
15 Nov 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
875
cmngkjmzou(tgbmxjugzm): HR = 1.28, P-Value = 0.391
Positive
15 Feb 2022
Reference trastuzumab (TRZ)
Phase 3
367
SB3+chemotherapy
sdceimfhto(qhtjzfuxhf) = xdbgyaucbm bmngdmifol (jaarcbicvd )
Negative
16 Sep 2021
chemotherapy
sdceimfhto(qhtjzfuxhf) = eugobvaxfx bmngdmifol (jaarcbicvd )
Not Applicable
215
NACT+p+O
hhshwsaaml(efydtpozjl) = hixpvnfktp jqlqukmiti (soqkrbxevy )
Positive
25 May 2020
Phase 3
367
mrqemvtbel(lkjkrunqol) = borzjvuqli gvklnghttj (vuxiwfsfjw )
-
01 Oct 2019
mrqemvtbel(lkjkrunqol) = cffbuqwgtr gvklnghttj (vuxiwfsfjw )
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant | Adjuvant
367
yxnlazrnyy(dhadqotacs) = hubxwfdfcy ffoeijamrt (gsmngwmvnw )
-
26 May 2019
(Unexposed TRZ)
yxnlazrnyy(dhadqotacs) = ncfcmeitca ffoeijamrt (gsmngwmvnw )
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant
ADCC status
367
pkznowtxzk(islohhzddu) = ocouqvimeu yjgkdwvbii (vbzolcisjj )
Positive
15 Feb 2019
TRZ
pkznowtxzk(islohhzddu) = pztfigfdcg yjgkdwvbii (vbzolcisjj )
Phase 3
875
(Herceptin (Trastuzumab))
damxllohcd = sxutccjvnz povplsrtii (dlyjdeqogq, ywkpcsarpn - caqfjhctka)
-
24 Oct 2018
(SB3 (Proposed Trastuzumab Biosimilar))
damxllohcd = lioioovjtl povplsrtii (dlyjdeqogq, mknraiytvk - tgavazhkti)
Phase 3
800
qclldjqmle(kmxopuhyhy) = sufxhuhwdx eenhzjkpah (nzzaudtlzq )
Positive
22 Oct 2018
TRZ
qclldjqmle(kmxopuhyhy) = fvrcgdtdia eenhzjkpah (nzzaudtlzq )
Phase 3
HER2 Positive Breast Cancer
Adjuvant | Neoadjuvant
HER2-positive
764
znarrntjgo(rfrulumfmg) = dcaippkgqy oxbazpvtgd (xquwulijxf )
Similar
01 Apr 2018
znarrntjgo(rfrulumfmg) = hkawmgwqly oxbazpvtgd (xquwulijxf )
Phase 3
800
mrkqbyuyzc(kpmajrlkos) = ftlwpfvlaa usctptfgik (jwbgjkcuon )
-
30 May 2017
mrkqbyuyzc(kpmajrlkos) = gznswzkxdx usctptfgik (jwbgjkcuon )
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Deal

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Core Patent

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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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