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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) · Commercial partner or holder: Reliance Life Sciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOFeb 2020permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
OmalizumabmoleculeReliance Life Sciencesdeveloper1 of 7markets0trials behind it13other products, same developer0rival developers in its markets

About Reliance Life Sciences omalizumab

Reliance Life Sciences received the first omalizumab permission in the world, in India in February 2020, for severe allergic asthma, as a powder to be made up before injection. It is the only omalizumab made in India.

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

Not listed by HC.

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
Remarks
First omalizumab biosimilar permitted in India.
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Same developer, other molecules

Other biosimilars in the Atlas developed by Reliance Life Sciences: Reliance Life Sciences adalimumab, Reliance Life Sciences bevacizumab, Reliance Life Sciences darbepoetin alfa, Reliance Life Sciences denosumab, Reliance Life Sciences etanercept, Reliance Life Sciences follitropin alfa, Reliance Life Sciences golimumab, Reliance Life Sciences infliximab, Reliance Life Sciences ranibizumab, Reliance Life Sciences rituximab, Reliance Life Sciences somatropin, Reliance Life Sciences trastuzumab, UstekiRel.

Chronology

Sources

All omalizumab biosimilars

Planning omalizumab biosimilar development?

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Data current to September 2026.