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TRASTUZUMAB BS (trastuzumab-bs)
TRASTUZUMAB BS (generic name: trastuzumab-bs) is a Regimen A or regimen B is used for HER2-overexpressing breast cancer. RegimenB is used for HER2-ove Monoclonal antibody drug developed by Pfizer Inc.. It is currently in preclinical development.
Regimen A or regimen B is used for HER2-overexpressing breast cancer. RegimenB is used for HER2-ove
Trastuzumab BS is a biosimilar of the antibody drug trastuzumab, which is an inhibitor of the receptor tyrosine-protein kinase erbB-2. It is being studied for the treatment of unresectable advanced or recurrent HER2-overexpressing gastric cancer.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. 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 | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +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-bs |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Regimen A or regimen B is used for HER2-overexpressing breast cancer. RegimenB is used for HER2-ove |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Trastuzumab BS is a monoclonal antibody, which is essentially a specially designed protein that acts like a targeted missile. It locks onto a specific protein called HER2 that appears in excessive amounts on certain cancer cells. By binding to HER2, the drug blocks cancer cells from receiving growth signals that tell them to multiply and spread. Beyond simply blocking growth signals, trastuzumab BS recruits the body's immune system to attack and eliminate cancer cells displaying HER2. It does this by tagging cancer cells so that natural killer cells and other immune components recognize them as threats and destroy them. This dual mechanism—blocking growth and activating immunity—makes the drug effective against HER2-positive cancers. Trastuzumab BS is a biosimilar version of the original trastuzumab, meaning it is manufactured differently but performs the same function in the body. It is approved for treating HER2-positive breast cancer and gastric cancer, cancers where HER2 overexpression drives aggressive growth. The biosimilar designation allows patients access to this important therapy with similar outcomes potentially at lower cost.
Approved indications
Pipeline indications
- Gastric Cancer — preclinical
Common side effects
Key clinical trials
- To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Brea (Phase 2)
- TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific A (Phase 2)
- Safety and Efficacy of Trastuzumab BS (N/A)
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 BS CI brief — competitive landscape report
- TRASTUZUMAB BS updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about TRASTUZUMAB BS
What is TRASTUZUMAB BS?
How does TRASTUZUMAB BS work?
Who makes TRASTUZUMAB BS?
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What drug class is TRASTUZUMAB BS in?
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Related
- Drug class: All Regimen A or regimen B is used for HER2-overexpressing breast cancer. RegimenB is used for HER2-ove drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing