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Herceptin biosimilars
14 approved
0 filed
13 Phase 3
All key patents expired
About Herceptin
Herceptin (trastuzumab) — originally marketed by Roche. Class: Antibody-drug conjugate (ADC). Target: HER2 receptor, subdomain IV. Area: Oncology. First approved 1998-01-01.
Approved biosimilars (14)
| Biosimilar | Sponsor | Phase | First approval | Country |
|---|---|---|---|---|
| Enhertu | Daiichi Sankyo | marketed | 2019-01-01 | |
| Kadcyla | Roche | marketed | 2013-01-01 | |
| Herceptin | Roche | marketed | 1998-01-01 | |
| HERZUMA | CELLTRION INC | marketed | ||
| Trastuzumab + Pertuzumab | Massachusetts General Hospital | marketed | ||
| Trastuzumab deruxtecan-nxki | Memorial Sloan Kettering Cancer Center | marketed | ||
| HERCESSI | ACCORD BIOPHARMA INC. | marketed | ||
| trastuzumab (H) | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | marketed | ||
| Trastuzumab (Herceptin) | Pfizer Inc. | marketed | ||
| Trastuzumab and Pertuzumab | Pfizer Inc. | marketed | ||
| OGIVRI | MYLAN GMBH | marketed | ||
| KANJINTI | AMGEN INC | marketed | ||
| Trastuzumab and Hyaluronidase-oysk | Adrienne G. Waks | marketed | ||
| ONTRUZANT | SAMSUNG BIOEPIS CO LTD | marketed |
Filed biosimilars under regulatory review (0)
Phase 3 biosimilars (13)
| Biosimilar | Sponsor | Phase | First approval | Country |
|---|---|---|---|---|
| Trastuzumab Injectable Product | Spanish Breast Cancer Research Group | phase 3 | ||
| trastuzumab and chemotherapy | Comprehensive Support Project for Oncology Research | phase 3 | ||
| Trastuzumab Injectable Solution | Spanish Breast Cancer Research Group | phase 3 | ||
| Trastuzumab IV | Hoffmann-La Roche | phase 3 | ||
| trastuzumab monotherapy | Comprehensive Support Project for Oncology Research | phase 3 | ||
| Trastuzumab+ chemotherapy | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | phase 3 | ||
| trastuzumab deruxtecan (T-DXd) | GI Innovation, Inc. | phase 3 | ||
| Trastuzumab/Hyaluronidase-oysk | National Cancer Institute (NCI) | phase 3 | ||
| Trastuzumab and neratinib | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | phase 3 | ||
| Trastuzumab Emtansine for Injection | Shanghai Miracogen Inc. | phase 3 | ||
| Trastuzumab Injection | Spanish Breast Cancer Research Group | phase 3 | ||
| Trastuzumab-EU | Pfizer | phase 3 | ||
| Trastuzumab SC | Dana-Farber Cancer Institute | phase 3 |
Originator patent timeline
Active patents (0)
Expired patents (0)
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Every regulatory action on Herceptin or any of its biosimilars: