TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ERELZI

ETANERCEPT-SZZS
Approved 2016-08-30
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2016-08-30
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Novartis
Active Ingredient: ETANERCEPT-SZZS

ERELZI Approval History

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What ERELZI Treats

4 FDA approvals

Originally approved for its first indication in 2016 . Covers 4 distinct patient populations.

  • Other (4)
Biosimilar for Enbrel

ERELZI is a lower-cost alternative to Enbrel 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.

ERELZI FDA Label Details

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Data Sources

FDA Approval: BLA761042 → Trials: ClinicalTrials.gov →

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