TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

HERCESSI

TRASTUZUMAB-STRF
Approved 2024-04-25
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-04-25
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

ACCORD BIOPHARMA INC.
Active Ingredient: TRASTUZUMAB-STRF

HERCESSI Approval History

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What HERCESSI Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
Biosimilar for Herceptin

HERCESSI is a lower-cost alternative to Herceptin with no clinically meaningful differences. Requires prescriber approval to substitute.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

HERCESSI FDA Label Details

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Data Sources

FDA Approval: BLA761346 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.