Home/Biosimilar Atlas/Ustekinumab/Yesintek / Usrenty

Yesintek / Usrenty

Ustekinumab biosimilar developed by Biocon Biologics, development code Bmab 1200. Reference product Stelara.

Brands by market: Yesintek (USA, EU); Usrenty (EU) · Commercial partner or holder: Biocon Biologics · Company profile

FDANov 2024approved

EMAFeb 2025authorised

MHRALicenseddate not shown

PMDANot listed

HCOct 2025approved

CDSCONot listed

EDENot listed

Approved or registered in 4 of 7 markets

Connections

Ustekinumabmolecule Biocon Biologicsdeveloper 4 of 7markets 0trials behind it 8other products, same developer 8rival developers in its markets

About Yesintek / Usrenty

Yesintek is Biocon's ustekinumab, approved in the United States in November 2024 and interchangeable since 2025, in Europe in early 2025 and in Canada later that year. Biocon added a second European name, Usrenty, in 2025. It is one of the products with which Biocon moved beyond its original insulins and cancer antibodies into immunology.

Status by market

FDA

United States · Yesintek

US Food and Drug AdministrationApproved

Brand

Yesintek

Holder or applicant

Biocon Biologics Inc.

Pathway

351(k)

Approved

Nov 2024

Application or permission

761406

Licence type

351(k) interchangeable, designated Apr 2025

Reference product in the Purple Book

Stelara

Marketing status (Purple Book)

Prescription, marketed

Presentations

45/0.5, 90/1 SC; 130/26 IV

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Yesintek

European Medicines Agency and European CommissionApproved

Brand

Yesintek

Holder or applicant

Biosimilar Collaborations Ireland Limited

Pathway

Centralised (Article 10(4))

Approved

Feb 2025

Application or permission

EMEA/H/C/006444

Presentations

see SmPC

Source

S017 (EMA) · checked Sep 2026

EMA

European Union · Usrenty

European Medicines Agency and European CommissionApproved

Brand

Usrenty

Holder or applicant

Biosimilar Collaborations Ireland Limited

Pathway

Centralised (Article 10(4))

Approved

Sep 2025

Application or permission

EMEA/H/C/006794

Presentations

see SmPC

Remarks

Second Biocon brand.

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Yesintek

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Yesintek

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

45 mg and 90 mg syringes and pens; 130 mg vial

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada · Yesintek

Health CanadaApproved

Brand

Yesintek

Holder or applicant

Biocon Biologics Canada INC

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Oct 2025

Application or permission

DIN 02562081, 02562103, 02562111

Presentations

45, 90 mg; 5 mg

Remarks

Also Yesintek I.V..

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Yesintek / Usrenty holds an approval, these are the other ustekinumab biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	7	Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Bio-Thera Solutions (Starjemza), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva)
EMA	7	Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva)
MHRA	7	Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva)
HC	5	Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Celltrion (Steqeyma), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva)

Same developer, other molecules

Other biosimilars in the Atlas developed by Biocon Biologics: Biocon human insulin, Bosaya / Aukelso / Vevzuo / Evfraxy, Fulphila / Vivlipeg / Biopegfil, Jobevne / Abevmy / Krabeva, Kirsty, Ogivri / CANMAb, Semglee, Yesafili.

Chronology

FDANov 2024Approved by FDA as Yesintek
EMAFeb 2025Authorised by the European Commission as Yesintek
FDAApr 2025Yesintek designated interchangeable
EMASep 2025Authorised by the European Commission as Usrenty
HCOct 2025Notice of Compliance, Health Canada as Yesintek

Sources

S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)
S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All ustekinumab biosimilars

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Data current to September 2026.