UstekiRel
Ustekinumab biosimilar developed by Reliance Life Sciences. Reference product Stelara.
Brands by market: UstekiRel (India) · Commercial partner or holder: Reliance Life Sciences
FDAnot listed
EMAnot listed
CDSCOApr 2023permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India · UstekiRel
Central Drugs Standard Control OrganisationApprovedBrand
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
Note
Brand name UstekiRel appears in the CDSCO record.
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOApr 2023CDSCO permission granted
Sources
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