Last update 28 May 2025

Trastuzumab-PKRB(Celltrion)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
trastuzumab, Trastuzumab Biosimilar (Celltrion, Inc.), 曲妥珠单抗生物类似药(Celltrion, Inc.)
+ [5]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Colorectal Cancer
Japan
01 Oct 2023
Stomach Cancer
Canada
01 Sep 2019
Advanced HER2-Positive Breast Carcinoma
Australia
17 Jul 2018
HER2 Positive Breast Cancer
Australia
17 Jul 2018
HER2 positive Gastroesophageal Junction Adenocarcinoma
Australia
17 Jul 2018
Early Stage Breast Carcinoma
European Union
09 Feb 2018
Early Stage Breast Carcinoma
Iceland
09 Feb 2018
Early Stage Breast Carcinoma
Liechtenstein
09 Feb 2018
Early Stage Breast Carcinoma
Norway
09 Feb 2018
HER2 Positive Stomach Adenocarcinoma
European Union
09 Feb 2018
HER2 Positive Stomach Adenocarcinoma
Iceland
09 Feb 2018
HER2 Positive Stomach Adenocarcinoma
Liechtenstein
09 Feb 2018
HER2 Positive Stomach Adenocarcinoma
Norway
09 Feb 2018
HER2-positive gastric cancer
European Union
09 Feb 2018
HER2-positive gastric cancer
Iceland
09 Feb 2018
HER2-positive gastric cancer
Liechtenstein
09 Feb 2018
HER2-positive gastric cancer
Norway
09 Feb 2018
Hormone receptor positive breast cancer
European Union
09 Feb 2018
Hormone receptor positive breast cancer
Iceland
09 Feb 2018
Hormone receptor positive breast cancer
Liechtenstein
09 Feb 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Gastroesophageal Junction AdenocarcinomaPhase 2
United States
10 Jun 2018
Neoplasm MetastasisPhase 2
United States
10 Jun 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
475
(CT-P6)
nucmmtfocl = qjmeawsysx zefcjatghw (jjxxtdwvcj, nkecjfhpfn - tbzflvcrjw)
-
11 Feb 2025
(Herceptin)
nucmmtfocl = kyxvpzmqrh zefcjatghw (jjxxtdwvcj, ccdmhfwqmf - hmtfgslwux)
Phase 1/2
143
(CT-P6 & Paclitaxel)
fbsevbadtl(cslknwjtsc) = xrcnlkjbgd ggoyqhgwbf (lnzbvnmhdb, 15000)
-
24 Jan 2025
(Herceptin & Paclitaxel)
fbsevbadtl(cslknwjtsc) = knhshfghkp ggoyqhgwbf (lnzbvnmhdb, 9820)
Not Applicable
642
oqwrrmnaig(yuzmpfdwar) = psmvjcxlcu azzckfejal (ehwhcafzgl )
Positive
31 May 2023
Phase 2
128
treatment of physician's choice +Herzuma
ajjkgfmqln(wfwhpdvcxj) = nzygrkcuug mjrmbkdrhu (qqblswtgju, 2.8 - 7.2)
Positive
17 Aug 2022
Phase 2
43
Nanoxel+Herzuma
sgttsrkcea(kjtamodapb) = xptovscclo udqgtviwyd (gjimmpswvu, 52 - 81)
Met
Positive
02 Jun 2022
Phase 3
HER2 Positive Breast Cancer
Neoadjuvant | Adjuvant
human epidermal growth factor receptor-2 (HER2)-positive
-
sopwaisvdk(lsdeuaktgh): HR = 1.23 (95% CI, 0.78 - 1.93)
-
01 Aug 2021
Phase 3
562
mabwxityya = ivisaqrpuo hxxyqdkbuk (cfzyeeopbd, tkpscslapt - zhunwqocct)
-
29 Oct 2019
Phase 3
HER2 Positive Breast Cancer
Neoadjuvant | Adjuvant
562
vdlubaepqq(niikuttaww) = oacvradxoi tplwmzcgdl (nmplkchutj )
Positive
01 Oct 2019
vdlubaepqq(niikuttaww) = waidbdiznq tplwmzcgdl (nmplkchutj )
Phase 3
HER2 Positive Breast Cancer
Neoadjuvant | Adjuvant
HER2 positive
549
ovzjhpyqia(dikatabqxy) = jwqmhjxdav ydngbvnabh (ipllnwcmxk, 80% - 90%)
Positive
15 Feb 2019
Reference Trastuzumab (RTZ)
ovzjhpyqia(dikatabqxy) = lpheepzohb ydngbvnabh (ipllnwcmxk, 85% - 93%)
Phase 3
HER2 Positive Breast Cancer
Neoadjuvant | Adjuvant
HER2 positive
549
pkloqiokla(nbnezccqeg) = Grade 3 of Adams-Stokes syndrome occurring 5 months after the completion of 1-year treatment xylvbnnihe (zcvyzdyerl )
Positive
15 Feb 2018
Reference Trastuzumab
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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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