Last reviewed · How we verify

Dupixent biosimilars

Complete Dupixent (DUPILUMAB) biosimilar landscape: 10 approved biosimilars, 0 filed, 2 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

10 approved 0 filed 2 Phase 3 All key patents expired

About Dupixent

Dupixent (DUPILUMAB) — originally marketed by Regeneron. Class: Interleukin-4 Receptor alpha Antagonist [EPC]. Target: Interleukin-4 receptor subunit alpha. Area: Immunology. First approved 2017-01-01.

Approved biosimilars (10)

BiosimilarSponsorPhaseFirst approvalCountry
Dupilumab - Standard Dose Johns Hopkins University marketed
Dupilumab therapy National Medical Research Center for Children's Health, Russian Federation marketed
Dupilumab Prefilled Syringe Jonathan A. Bernstein, MD marketed
Dupilumab - Discontinuation Johns Hopkins University marketed
Dupilumab - Dose Reduction Johns Hopkins University marketed
Dupilumab step-down Nantes University Hospital marketed
Dupilumab Injectable Product University of Virginia marketed
Dupilumab (SAR231893) Sanofi marketed
Dupilumab Injection Gan & Lee Pharmaceuticals. marketed
Dupilumab Only Product Eric Simpson marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (2)

BiosimilarSponsorPhaseFirst approvalCountry
Dupilumab (SAR231893/REGN668) Sanofi phase 3
Dupilumab/Dupixent McMaster University phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

Subscribe to biosimilar updates

Every regulatory action on Dupixent or any of its biosimilars:

Related