How many Epogen biosimilars are approved?

Drug Landscape tracks 1 approved Epogen biosimilars across global regulators. 0 additional applications are filed and 5 are in Phase 3.

Is Epogen still patent-protected?

All tracked patents on Epogen have expired in tracked territories.

What is a biosimilar?

A biosimilar is a biological medicine highly similar to an already-approved reference biologic (the originator), with no clinically meaningful differences in safety, purity, or potency. Approved via abbreviated regulatory pathways once the originator's data exclusivity and patents expire.

Last reviewed 2026-06-10 · How we verify

Epogen biosimilars

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Complete Epogen (EPOETIN ALFA) biosimilar landscape: 1 approved biosimilars, 0 filed, 5 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

1 approved 0 filed 5 Phase 3 All key patents expired

About Epogen

Epogen (EPOETIN ALFA) — originally marketed by Amgen. Class: Erythropoiesis-stimulating Agent. Target: Erythropoietin receptor. Area: Metabolic. First approved 1989-01-01.

Approved biosimilars (1)

Biosimilar	Sponsor	Phase	First approval	Country
Epogen	Amgen	marketed	1989-01-01

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (5)

Biosimilar	Sponsor	Phase
Epoetin Alfa-BioSimilar	Hospital de Clinicas de Porto Alegre	phase 3
Epoetin Alfa-BioManguinhos	Hospital de Clinicas de Porto Alegre	phase 3
HX575 epoetin alfa	Sandoz	phase 3
HX575 epoetin alfa Hexal AG	Sandoz	phase 3
HX575 epoetin alfa (Sandoz)	Sandoz	phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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Every regulatory action on Epogen or any of its biosimilars:

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing