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PF-05280014
PF-05280014 is a HER2-targeted monoclonal antibody (trastuzumab biosimilar) Biologic drug developed by Pfizer. It is currently in Phase 3 development for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer, HER2-positive gastric cancer. Also known as: Trastuzumab-Pfizer.
PF-05280014 is a biosimilar of trastuzumab that binds to HER2 on cancer cells to inhibit growth and promote immune-mediated cell death.
PF-05280014 is being studied in clinical trials for various breast cancer conditions, including HER2/Neu Positive, Recurrent Breast Carcinoma, Stage IV Breast Cancer, Metastatic Breast Cancer, and Anatomic Stage II Breast Cancer AJCC v8. The exact mechanism of PF-05280014 is unknown, but it is being investigated in combination with other interventions such as Pertuzumab.
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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 | PF-05280014 |
|---|---|
| Also known as | Trastuzumab-Pfizer |
| Sponsor | Pfizer |
| Drug class | HER2-targeted monoclonal antibody (trastuzumab biosimilar) |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PF-05280014 is a monoclonal antibody designed as a biosimilar to trastuzumab (Herceptin), targeting human epidermal growth factor receptor 2 (HER2) expressed on cancer cells. By binding to HER2, it blocks HER2-mediated signaling and recruits immune cells to destroy HER2-positive tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early-stage breast cancer
- HER2-positive gastric cancer
Common side effects
- Infusion-related reactions
- Cardiotoxicity / left ventricular dysfunction
- Nausea
- Fatigue
- Diarrhea
Key clinical trials
- 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)
- Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (PHASE1, PHASE2)
- TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (PHASE2)
- An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (PHASE4)
- Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal 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:
- PF-05280014 CI brief — competitive landscape report
- PF-05280014 updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about PF-05280014
What is PF-05280014?
How does PF-05280014 work?
What is PF-05280014 used for?
Who makes PF-05280014?
Is PF-05280014 also known as anything else?
What drug class is PF-05280014 in?
What development phase is PF-05280014 in?
What are the side effects of PF-05280014?
What does PF-05280014 target?
Related
- Drug class: All HER2-targeted monoclonal antibody (trastuzumab biosimilar) drugs
- Target: All drugs targeting HER2 (human epidermal growth factor receptor 2)
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for HER2-positive metastatic breast cancer
- Indication: Drugs for HER2-positive early-stage breast cancer
- Indication: Drugs for HER2-positive gastric cancer
- Also known as: Trastuzumab-Pfizer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing