BLAIV (INFUSION)POWDER
Approved
Jan 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
ONTRUZANT (trastuzumab) by Samsung Bioepis is her2/neu/cerbb2 antagonists [moa]. First approved in 2019.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONTRUZANT is a monoclonal antibody biosimilar to trastuzumab that targets HER2/neu receptors on cancer cells. It is administered intravenously as a powder for reconstitution and is indicated for HER2-positive breast cancer and gastric cancer. The drug works by blocking HER2 signaling, inhibiting tumor growth and survival.
$0.002BPart D
PeakAs a peak-stage biosimilar with modest Part D penetration, teams are focused on market share capture and managed care contracting rather than growth expansion.
Mechanism of Action
HER2/Neu/cerbB2 Antagonists
Pharmacologic Class:
HER2/neu Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
BEYOND Study: A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Started Jun 2026
109 enrolled
Breast Cancer
HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer
Started Jun 2026
87 enrolled
HER2-positive Metastatic Breast CancerHER2-positive Advanced Breast Cancer
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
Started May 2026
60 enrolled
HER2-positive Recurrent or Metastatic Breast Cancer
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
Started May 2026
650 enrolled
HER2-positive Breast Cancer
A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer
Started Apr 2026
596 enrolled
HER2-positive Breast Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.