Axberi

Enoxaparin sodium biosimilar developed by Baxter. Reference product Clexane (Lovenox in the United States).

Brands by market: Axberi (Canada) · Commercial partner or holder: Baxter

FDAnot listed

EMAnot listed

PMDAnot listed

HCJul 2023approved

CDSCOnot listed

EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

PMDA

Japan

Not listed by PMDA.

Canada · Axberi

Health CanadaApproved

Brand

Axberi

Holder or applicant

Baxter Corporation

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Jul 2023

Application or permission

DIN 02539977, 02539985, 02540002, 02540010, 02540045, 02540029, 02540037

Presentations

100, 30, 40, 60, 80 mg; 120, 150 mg

Note

Also Axberi Hp.

Source

S022

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Chronology

HCJul 2023Notice of Compliance, Health Canada

Sources

S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)

All enoxaparin sodium biosimilars

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Data current to September 2026.