BLAIV (INFUSION)POWDER
Approved
Jan 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ONTRUZANT (trastuzumab) by Samsung Bioepis is her2/neu/cerbb2 antagonists [moa]. First approved in 2019.
Drug data last refreshed 27m ago · AI intelligence enriched 1mo 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)
A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer
Started Aug 2026
220 enrolled
Hormone Receptor PositiveHER2-low or HER2-ultralowUnresectable or Metastatic Breast Cancer
A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer
Started Aug 2026
27 enrolled
Colorectal CancerAdenocarcinoma of the ColonAdenocarcinoma of the Rectum
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
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
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
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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.