Tyenne
Tocilizumab biosimilar developed by Fresenius Kabi, development code MSB11456. Reference product Actemra (RoActemra in the European Union).
Brands by market: Tyenne (USA, EU) · Commercial partner or holder: Fresenius Kabi
FDAMar 2024approved
EMASep 2023authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Tyenne
US Food and Drug AdministrationApprovedBrand
Tyenne
Holder or applicant
Fresenius Kabi USA, LLC
Pathway
351(k)
Approved
Mar 2024
Application or permission
761275
Licence type
351(k) biosimilar, not interchangeable
Presentations
80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials; 162 mg/0.9 mL SC (BLA 761449, March 2025)
Source
S001, S016
EMA
European Union · Tyenne
European Medicines Agency and European CommissionApprovedBrand
Tyenne
Holder or applicant
Fresenius Kabi Deutschland GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2023
Application or permission
EMEA/H/C/005781
Indications as licensed
RA, GCA, sJIA, pJIA, CRS, COVID-19
Presentations
see SmPC
Note
First EU tocilizumab biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMASep 2023Authorised by the European Commission as Tyenne
- FDAMar 2024Approved by FDA as Tyenne
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)
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