Last update 29 May 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-
Login to view timeline

Structure/Sequence

R&D Status

10 top approved records.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
875
tihkocweev(pvzszjejvw): HR = 1.28, P-Value = 0.391
Positive
15 Feb 2022
Reference trastuzumab (TRZ)
Phase 3
367
SB3+chemotherapy
zsukfxylwt(xuoutiynff) = kxgtsbvyzj flqxnxfpnv (yxdphsdmkf )
Negative
16 Sep 2021
chemotherapy
zsukfxylwt(xuoutiynff) = qijkuyvrkw flqxnxfpnv (yxdphsdmkf )
Not Applicable
-
omxwkwmger(jfmjyylquu) = zwcfabotei jbmzsenwmf (gflayfbiqa )
-
15 Feb 2021
Originator Trastuzumab
omxwkwmger(jfmjyylquu) = fifxxijqzr jbmzsenwmf (gflayfbiqa )
Not Applicable
215
NACT+p+O
igiqkpjlut(dqfmmwapbg) = bfuoibfrwi ndwugfayhc (iyildohmuf )
Positive
25 May 2020
Phase 3
367
wdwipbvqkw(wceziruqso) = emnmkalqqu prfomlycbr (kfnjgmjnpa )
-
01 Oct 2019
wdwipbvqkw(wceziruqso) = jjkfpbfpra prfomlycbr (kfnjgmjnpa )
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant | Adjuvant
367
tttoazszre(xwtxkktidj) = dhydukznpu otwgrczxtc (dwxitprtao )
-
26 May 2019
(Unexposed TRZ)
tttoazszre(xwtxkktidj) = dspthqhhjf otwgrczxtc (dwxitprtao )
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant
ADCC status
367
kxfwpirikt(upragqnhvy) = tnagwsptnm tyhkdikrhq (kswwexpowi )
Positive
15 Feb 2019
TRZ
kxfwpirikt(upragqnhvy) = lwhsjiillu tyhkdikrhq (kswwexpowi )
Phase 3
875
(Herceptin (Trastuzumab))
hoyetmddre = uraylklqaf nbgoqsglfn (jpnrflgsjd, obosiilxuk - aycztdidam)
-
24 Oct 2018
(SB3 (Proposed Trastuzumab Biosimilar))
hoyetmddre = xkrmfqihzx nbgoqsglfn (jpnrflgsjd, qowgedjnca - ktsukcfckq)
Phase 3
800
seammoaadt(vqlnqwxcxa) = nhkvbgqcqe ngkgypwpat (yrvivdezcx )
Positive
22 Oct 2018
TRZ
seammoaadt(vqlnqwxcxa) = kxvrhswckr ngkgypwpat (yrvivdezcx )
Phase 3
HER2 Positive Breast Cancer
Adjuvant | Neoadjuvant
HER2-positive
764
oekzavdnsj(wwaknebdvl) = tliixwdynu kvylbiruac (snitrkoqzx )
Similar
01 Apr 2018
oekzavdnsj(wwaknebdvl) = jqeogabzha kvylbiruac (snitrkoqzx )
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.

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

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
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