UstekiRel

Ustekinumab biosimilar developed by Reliance Life Sciences. Reference product Stelara.

Brands by market: UstekiRel (India) · Commercial partner or holder: Reliance Life Sciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOApr 2023permitted
EDENot listed
Approved or registered in 1 of 7 markets

About UstekiRel

UstekiRel is Reliance Life Sciences' ustekinumab, permitted in India in April 2023 for plaque psoriasis, with psoriatic arthritis added in December 2024. It is the only ustekinumab biosimilar made in India, and one of the few Indian permissions where the published record names the brand.

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 · UstekiRel

Central Drugs Standard Control OrganisationApproved
Brand
UstekiRel
Holder or applicant
Reliance Life Sciences Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Apr 2023
Application or permission
MF/BIO/23/000037; drug substance MF/BIO/23/000046; additional indication MF/BIO/24/000133
Indications as licensed
Plaque psoriasis at permission; psoriatic arthritis added December 2024
Presentations
45 mg/0.5 mL and 90 mg/mL PFS
Remarks
Brand name UstekiRel appears in the CDSCO record.
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 omalizumab, Reliance Life Sciences ranibizumab, Reliance Life Sciences rituximab, Reliance Life Sciences somatropin, Reliance Life Sciences trastuzumab.

Chronology

Sources

All ustekinumab biosimilars

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Data current to September 2026.