Drug Type Biosimilar, Monoclonal antibody |
Synonyms Herceptin biosimilar, Trastuzumab biosimilar, ALT 02 + [6] |
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 |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
Regulation- |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Breast Cancer | NDA/BLA | CN | 27 Apr 2023 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | CN | 29 Apr 2020 | |
Esophageal Carcinoma | Phase 1 | CN | - | |
Esophageal Carcinoma | Phase 1 | - | - | |
Esophageal Carcinoma | Phase 1 | - | - | |
Stomach Cancer | Phase 1 | CN | - | |
Stomach Cancer | Phase 1 | - | - | |
Stomach Cancer | Phase 1 | - | - |
Phase 3 | 315 | (Arm I (Combination Chemotherapy, Surgery, Radiation)) | ilghhfewgd(fiwvxunuid) = drnyvhanbo sqijjpwkss (uieoztblpk, dtlwcsuban - ietgxclsjb) View more | - | 12 Jun 2023 | ||
(Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)) | ilghhfewgd(fiwvxunuid) = uxpepyrgco sqijjpwkss (uieoztblpk, ufoyktzudt - npxlgiurgt) View more |