How many Enhertu biosimilars are approved?

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

Is Enhertu still patent-protected?

All tracked patents on Enhertu 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 2026-05-17 · How we verify

Enhertu biosimilars

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

Complete Enhertu (trastuzumab-deruxtecan) biosimilar landscape: 1 approved biosimilars, 0 filed, 1 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

1 approved 0 filed 1 Phase 3 All key patents expired

About Enhertu

Enhertu (trastuzumab-deruxtecan) — originally marketed by Daiichi Sankyo. Target: Receptor tyrosine-protein kinase erbB-2. Area: Oncology. First approved 2019-01-01.

Approved biosimilars (1)

Biosimilar	Sponsor	Phase	First approval	Country
Trastuzumab deruxtecan-nxki	Memorial Sloan Kettering Cancer Center	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (1)

Biosimilar	Sponsor	Phase	First approval	Country
trastuzumab deruxtecan (T-DXd)	GI Innovation, Inc.	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 Enhertu or any of its biosimilars: