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MSB11456
MSB11456 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling.
MSB11456 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling. Used for HER2-positive breast cancer, HER2-positive gastric cancer.
At a glance
| Generic name | MSB11456 |
|---|---|
| Sponsor | Fresenius Kabi SwissBioSim GmbH |
| Drug class | Monoclonal antibody (biosimilar) |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
MSB11456 is a proposed biosimilar to trastuzumab (Herceptin), a monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2) on cancer cells. By blocking HER2 signaling, it inhibits cell proliferation and promotes antibody-dependent cellular cytotoxicity (ADCC) in HER2-overexpressing tumors. As a biosimilar, it is designed to have comparable efficacy and safety to the reference trastuzumab product.
Approved indications
- HER2-positive breast cancer
- HER2-positive gastric cancer
Common side effects
- Cardiotoxicity / left ventricular dysfunction
- Infusion reactions
- Nausea and vomiting
- Diarrhea
- Fatigue
Key clinical trials
- MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis (PHASE3)
- Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456 (PHASE1)
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:
- MSB11456 CI brief — competitive landscape report
- MSB11456 updates RSS · CI watch RSS
- Fresenius Kabi SwissBioSim GmbH portfolio CI