Last reviewed · How we verify
Trastuzumab biosimilar
At a glance
| Generic name | Trastuzumab biosimilar |
|---|---|
| Also known as | Samfenet, Trazimera®, Ogivri®, Herzuma®, Ontruzant® |
| Sponsor | Jin-Hee Ahn |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Fatigue
- Alopecia
- Nausea
- Diarrhea
- Peripheral sensory neuropathy
- Anemia
- Mucositis oral
- Neutrophil count decreased
- Dermatitis radiation
- Myalgia
- Bone pain
- Vomiting
Key clinical trials
- A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. (PHASE1)
- Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (PHASE2)
- Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery (PHASE2)
- Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib (PHASE2)
- Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (PHASE2)
- Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trastuzumab biosimilar CI brief — competitive landscape report
- Trastuzumab biosimilar updates RSS · CI watch RSS
- Jin-Hee Ahn portfolio CI