How many H5G1.1 biosimilars are approved?

Drug Landscape tracks 5 approved H5G1.1 biosimilars across global regulators. 0 additional applications are filed and 1 are in Phase 3.

Is H5G1.1 still patent-protected?

All tracked patents on H5G1.1 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 2026-05-14 · How we verify

H5G1.1 biosimilars

Complete H5G1.1 (ECULIZUMAB) biosimilar landscape: 5 approved biosimilars, 0 filed, 1 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

5 approved 0 filed 1 Phase 3 All key patents expired

About H5G1.1

H5G1.1 (ECULIZUMAB) — originally marketed by AstraZeneca. Class: Complement Inhibitor [EPC]. Target: C5. Area: Neuroscience. First approved 2007-01-01.

Approved biosimilars (5)

Biosimilar	Sponsor	Phase
EPYSQLI	SAMSUNG BIOEPIS CO LTD	marketed
BKEMV	AMGEN INC	marketed
Eculizumab administration	University Hospital, Rouen	marketed
Eculizumab (Soliris®)	Massachusetts General Hospital	marketed
Eculizumab+IVMP	Chinese PLA General Hospital	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (1)

Biosimilar	Sponsor	Phase	First approval	Country
Eculizumab Injection	Wuhan Createrna Science and Technology Co., Ltd	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 H5G1.1 or any of its biosimilars: