How many Leqembi biosimilars are approved?

Drug Landscape tracks 1 approved Leqembi biosimilars across global regulators. 0 additional applications are filed and 2 are in Phase 3.

Is Leqembi still patent-protected?

All tracked patents on Leqembi 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

Leqembi biosimilars

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

Complete Leqembi (LECANEMAB) biosimilar landscape: 1 approved biosimilars, 0 filed, 2 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

1 approved 0 filed 2 Phase 3 All key patents expired

About Leqembi

Leqembi (LECANEMAB) — originally marketed by Eisai. Class: Amyloid Beta-directed Antibody [EPC]. Target: Amyloid beta A4 protein. Area: Immunology. First approved 2023-01-01.

Approved biosimilars (1)

Biosimilar	Sponsor	Phase	First approval	Country
LEQEMBI	EISAI INC	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (2)

Biosimilar	Sponsor	Phase	First approval	Country
Lecanemab SC	Eisai Inc.	phase 3
Lecanemab IV	Eisai Inc.	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 Leqembi or any of its biosimilars:

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