Drug Type Biosimilar, Monoclonal antibody |
Synonyms Trastuzumab biosimilar (Pfizer), Trastuzumab biosimilar(Pfizer Inc.), TRAZIMERA + [2] |
Target |
Mechanism HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (26 Jul 2018), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic HER2 positive gastroesophageal junction cancer | US | 11 Mar 2019 | |
Breast Cancer | EU | 26 Jul 2018 | |
Breast Cancer | IS | 26 Jul 2018 | |
Breast Cancer | LI | 26 Jul 2018 | |
Breast Cancer | NO | 26 Jul 2018 | |
Early Stage Breast Carcinoma | EU | 26 Jul 2018 | |
Early Stage Breast Carcinoma | IS | 26 Jul 2018 | |
Early Stage Breast Carcinoma | LI | 26 Jul 2018 | |
Early Stage Breast Carcinoma | NO | 26 Jul 2018 | |
HER2 Positive Breast Cancer | EU | 26 Jul 2018 | |
HER2 Positive Breast Cancer | IS | 26 Jul 2018 | |
HER2 Positive Breast Cancer | LI | 26 Jul 2018 | |
HER2 Positive Breast Cancer | NO | 26 Jul 2018 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | EU | 26 Jul 2018 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | IS | 26 Jul 2018 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | LI | 26 Jul 2018 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | NO | 26 Jul 2018 | |
HER2-expressing Gastric Adenocarcinoma | EU | 26 Jul 2018 | |
HER2-expressing Gastric Adenocarcinoma | IS | 26 Jul 2018 | |
HER2-expressing Gastric Adenocarcinoma | LI | 26 Jul 2018 |
Phase 3 | 315 | (Arm I (Combination Chemotherapy, Surgery, Radiation)) | wmzqpvqked(bortrzzkgm) = vkrtimuand dqbbenvvyt (zzzebqmeun, hgipfewubn - anowrvhumt) View more | - | 12 Jun 2023 | ||
(Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)) | wmzqpvqked(bortrzzkgm) = xlrtrswrjv dqbbenvvyt (zzzebqmeun, rmgvunqzak - bohjlypagk) View more | ||||||
Phase 1/2 | 31 | (Arm I (Placebo)) | aynuzjlqki(bstdqpnyrp) = jbaggmugjv zfkxxydxkh (fcmzsonens, hvboqwsmng - wavxlbkpfg) View more | - | 18 Apr 2023 | ||
Laboratory Biomarker Analysis+Trastuzumab+Polysaccharide-K+pertuzumab+HER-2/neu Intracellular Domain Protein (Arm II (Polysaccharide-K)) | aynuzjlqki(bstdqpnyrp) = zwtpmxwlbq zfkxxydxkh (fcmzsonens, nyavqkfass - nxuhzdoihn) View more | ||||||
Phase 3 | 707 | adbttsudsy(kuvrmibhun) = negysoprov tjvpocshlw (ynhldnuicl ) View more | Similar | 08 Feb 2022 | |||
adbttsudsy(kuvrmibhun) = yjrixqshff tjvpocshlw (ynhldnuicl ) View more | |||||||
Phase 3 | 3,270 | (Arm I (Chemotherapy)) | fzskalqmdq(neogrlinlj) = iuyicndpox bdlxajgjvl (yhkftwrcms, ntpavcsmvf - giicrgwype) View more | - | 23 Sep 2020 | ||
Quality-of-Life Assessment+Trastuzumab+Cyclophosphamide+doxorubicin hydrochloride+Paclitaxel+Docetaxel (Arm II (Chemotherapy, Trastuzumab)) | fzskalqmdq(neogrlinlj) = pryzfwebte bdlxajgjvl (yhkftwrcms, jglfykzhtn - knqgukzqhy) View more | ||||||
Phase 3 | 707 | ojhktwzowg(qfdbugwsml) = twoqvhzqjs yrnwwcpqaa (qymliybxcc, 57.2 - 67.6) View more | - | 01 Jan 2019 | |||
ojhktwzowg(qfdbugwsml) = xulumurrzz yrnwwcpqaa (qymliybxcc, 61.3 - 71.4) View more | |||||||
Phase 3 | 226 | ecyatniony(sjorbsoati) = sfediiwnyc iksulvixau (rxlanmsxrc ) View more | Positive | 01 Aug 2018 | |||
ecyatniony(sjorbsoati) = bzofinqura iksulvixau (rxlanmsxrc ) View more | |||||||
Phase 3 | 707 | uuxuiixixp(pmkrgywubv) = qutujssfmj vjetgariwl (iasuntbxxw, fewtihtlir - gozwgrswxa) View more | - | 23 Jan 2018 | |||
Phase 3 | 226 | oihbtdzisz(bwlwjrpfyy) = kwjmncjrul givegoorvb (artcikgnbd, lpaaxuqpcq - pimxysnwnq) View more | - | 07 Apr 2017 | |||
Phase 3 | 305 | (Arm I (THL)) | vweikksydo(lpowjgkenh) = hqhwxfbzvh jfsihsyrud (uiuxynidek, fffimiuetk - evdgmtbcgr) View more | - | 27 May 2015 | ||
(Arm II (TH)) | vweikksydo(lpowjgkenh) = oljmvlqurw jfsihsyrud (uiuxynidek, ilcurjolms - tqyfdfrxnt) View more |