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Trastuzumab-EU
Trastuzumab-EU is a HER2/neu receptor antagonist Biologic drug developed by Pfizer. It is currently in Phase 3 development for Adjuvant treatment of HER2-positive breast cancer, Treatment of HER2-positive metastatic breast cancer.
Trastuzumab-EU is a monoclonal antibody that targets the HER2/neu receptor.
Trastuzumab-EU is a biosimilar of the antibody drug Trastuzumab, which is an inhibitor of the receptor tyrosine-protein kinase erbB-2. It is used to treat HER2-positive early breast cancer or locally advanced breast cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Trastuzumab-EU |
|---|---|
| Sponsor | Pfizer |
| Drug class | HER2/neu receptor antagonist |
| Target | HER2 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
It works by binding to the HER2 protein on the surface of cancer cells, which can help slow or stop the growth of the tumor. This is particularly useful for treating cancers that overexpress the HER2 protein, such as certain types of breast cancer.
Approved indications
- Adjuvant treatment of HER2-positive breast cancer
- Treatment of HER2-positive metastatic breast cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Headache
- Musculoskeletal pain
Key clinical trials
- A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. (PHASE1)
- 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)
- Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study (PHASE2)
- Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer. (PHASE3)
- To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (PHASE1)
- A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer (PHASE3)
- A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects (PHASE1)
- Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic 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-EU CI brief — competitive landscape report
- Trastuzumab-EU updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Trastuzumab-EU
What is Trastuzumab-EU?
How does Trastuzumab-EU work?
What is Trastuzumab-EU used for?
Who makes Trastuzumab-EU?
What drug class is Trastuzumab-EU in?
What development phase is Trastuzumab-EU in?
What are the side effects of Trastuzumab-EU?
What does Trastuzumab-EU target?
Related
- Drug class: All HER2/neu receptor antagonist drugs
- Target: All drugs targeting HER2
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of HER2-positive breast cancer
- Indication: Drugs for Treatment of HER2-positive metastatic breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing