Myxredlin

Insulin human biosimilar developed by Baxter. Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).

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

FDAnot listed

EMAnot listed

PMDAnot listed

HCAug 2022approved

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 · Myxredlin

Health CanadaApproved

Brand

Myxredlin

Holder or applicant

Baxter Corporation

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Aug 2022

Application or permission

DIN 02529602

Presentations

1 unit/mL intravenous infusion bag

Note

Flagged as a biosimilar in the Drug Product Database.

Source

S022

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Chronology

HCAug 2022Notice of Compliance, Health Canada

Sources

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

All insulin human biosimilars

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Data current to September 2026.