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 · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCJul 2023approved
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Axberi
Axberi is Baxter's enoxaparin for Canada, approved in July 2023, the most recent of the Canadian enoxaparin biosimilars, with a higher-strength form.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada · Axberi
Health CanadaApprovedBrand
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
Remarks
Also Axberi Hp.
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Axberi holds an approval, these are the other enoxaparin sodium biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| HC | 4 | Fresenius Kabi (Elonox), Juno Pharma Canada (Noromby), Sandoz (Inclunox), Techdow (Inhixa) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Baxter: Inpremzia, Myxredlin.
Chronology
- HCJul 2023Notice of Compliance, Health Canada
Sources
Planning enoxaparin sodium biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.