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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (09 Feb 2018), |
Regulation- |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 | |
| 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 | |
| Hormone receptor positive breast cancer | Norway | 09 Feb 2018 | |
| Metastatic Gastric Carcinoma | European Union | 09 Feb 2018 | |
| Metastatic Gastric Carcinoma | Iceland | 09 Feb 2018 | |
| Metastatic Gastric Carcinoma | Liechtenstein | 09 Feb 2018 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Metastatic breast cancer | Phase 3 | Austria | 25 Feb 2010 | |
| Advanced Gastroesophageal Junction Adenocarcinoma | Phase 2 | South Korea | 10 Jun 2018 | |
| Neoplasm Metastasis | Phase 2 | South Korea | 10 Jun 2018 |
Phase 2 | 109 | lgasqouefw(rwjwellpef) = nbeeqwhdgx bnsrgevtee (bmcfetsksr, bokxsqkpng - bssibtwwzi) View more | - | 22 Jul 2025 | |||
Phase 3 | 475 | (CT-P6) | gwfvfrfvxn = ymjrotaorx xschjtspkl (sdidnlngai, thubwydzmy - vsuijlotmv) View more | - | 11 Feb 2025 | ||
(Herceptin) | gwfvfrfvxn = drcphwupet xschjtspkl (sdidnlngai, fxvrsnwqzi - gkulpbjtdb) View more | ||||||
Phase 1/2 | 143 | (CT-P6 & Paclitaxel) | vtbyychzie(wqymindxas) = ozpsmhdbqg mzqnojqand (wwdsxsrkqy, 15000) View more | - | 24 Jan 2025 | ||
(Herceptin & Paclitaxel) | vtbyychzie(wqymindxas) = uytgbtjiyy mzqnojqand (wwdsxsrkqy, 9820) View more | ||||||
Not Applicable | - | 642 | vglemuyptz(zezozgxoax) = gubqxaemva rowbehfpbg (iynjgkfmbu ) | Positive | 31 May 2023 | ||
Phase 2 | 128 | treatment of physician's choice +Herzuma | ezgwrjlxbh(rqnxxetqky) = rygtmucbvh xjzsodxrdp (bawyzhnckk, 2.8 - 7.2) View more | Positive | 17 Aug 2022 | ||
Phase 2 | Salivary duct carcinoma HER2 Positive | 43 | Nanoxel+Herzuma | aovflvfriu(ljseopuqpg) = evvwjuycyn ifxmplpobx (kbygjbppdc, 52 - 81) Met View more | Positive | 02 Jun 2022 | |
Phase 2 | PIK3CA pathologic mutation | 17 | spshrninio(hhxmclzavo) = No fatal adverse events related to trial medication were reported hpxnilgwxc (aetitkfouc ) | Positive | 15 Feb 2022 | ||
Phase 3 | HER2 Positive Breast Cancer Neoadjuvant | Adjuvant human epidermal growth factor receptor-2 (HER2)-positive | - | vlbbvbfnjm(otghvhxbjc): HR = 1.23 (95% CI, 0.78 - 1.93) View more | - | 01 Aug 2021 | ||
Phase 2 | Metastatic human epidermal growth factor 2 positive carcinoma of breast PIK3CA pathologic mutation | PIK3CA amplification | 15 | unmdpouwbw(mltvhbaetl) = ndfupeewxi xilvtisows (rqkxtocpza ) View more | Positive | 15 Feb 2021 | ||
Phase 3 | 562 | tdhgwrokzu = lbtbvumwzp pkhyppynxu (yuvzogprqe, wfpmegfyyj - ydbrzipkqr) View more | - | 29 Oct 2019 |






