Otulfi / Fymskina
Ustekinumab biosimilar developed by Formycon, development code FYB202. Reference product Stelara.
Brands by market: Otulfi (USA, EU); Fymskina (EU) · Commercial partner or holder: Fresenius Kabi · Company profile
FDASep 2024approved
EMASep 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCDec 2024approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
About Otulfi / Fymskina
Otulfi is the ustekinumab developed by Formycon of Germany and sold by Fresenius Kabi, approved in the United States and Europe in the same month, September 2024, and in Canada in December. Formycon also holds a second European name, Fymskina, under its own licence. Otulfi is interchangeable in the United States.
Status by market
FDA
United States · Otulfi
US Food and Drug AdministrationApprovedBrand
Otulfi
Holder or applicant
Fresenius Kabi USA, LLC
Pathway
351(k)
Approved
Sep 2024
Application or permission
761379
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 · Otulfi
European Medicines Agency and European CommissionApprovedBrand
Otulfi
Holder or applicant
Fresenius Kabi Deutschland GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2024
Application or permission
EMEA/H/C/006544
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Fymskina
European Medicines Agency and European CommissionApprovedBrand
Fymskina
Holder or applicant
Formycon AG
Pathway
Centralised (Article 10(4))
Approved
Sep 2024
Application or permission
EMEA/H/C/005805
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Otulfi
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Otulfi
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.
HC
Canada · Otulfi
Health CanadaApprovedBrand
Otulfi
Holder or applicant
Fresenius Kabi Canada LTD
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Dec 2024
Application or permission
DIN 02554283, 02554291, 02554305
Presentations
45, 90 mg; 5 mg
Remarks
Also Otulfi I.V..
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Otulfi / Fymskina by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| FYB202 | Bioeq | Stelara | Phase 3 | Comparative efficacy | Completed | Nov 2020 | Jun 2021 | NCT04595409 |
Other developers in the same markets
Where Otulfi / Fymskina 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), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Samsung Bioepis (Pyzchiva) |
| EMA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| MHRA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| HC | 5 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Samsung Bioepis (Pyzchiva) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Formycon: Ahzantive / Baiama.
Chronology
- EMASep 2024Authorised by the European Commission as Fymskina
- EMASep 2024Authorised by the European Commission as Otulfi
- FDASep 2024Approved by FDA as Otulfi
- HCDec 2024Notice of Compliance, Health Canada as Otulfi
- FDAApr 2025Otulfi designated interchangeable
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)
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