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Reliance Life Sciences omalizumab

Omalizumab biosimilar developed by Reliance Life Sciences. Reference product Xolair.

Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Reliance Life Sciences
FDAnot listed
EMAnot listed
CDSCOFeb 2020permitted
EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Reliance Life Sciences Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Feb 2020
Application or permission
MF/BIO/20/000009; drug substance MF/BIO/20/000011
Indications as licensed
Moderate to severe persistent allergic asthma in adults
Presentations
150 mg lyophilised powder for injection
Note
First omalizumab biosimilar permitted in India.
Source
S011
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All omalizumab biosimilars

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Data current to September 2026.