Tofidence / Tocilizumab STADA
Tocilizumab biosimilar developed by Bio-Thera Solutions, development code BAT1806. Reference product Actemra (RoActemra in the European Union).
Brands by market: Tofidence (USA); Tocilizumab STADA (EU, previously Tofidence) · Commercial partner or holder: Biogen (USA); Stada (EU)
FDASep 2023approved
EMAJun 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Tofidence
US Food and Drug AdministrationApprovedBrand
Tofidence
Holder or applicant
Biogen MA Inc.
Pathway
351(k)
Approved
Sep 2023
Application or permission
761354
Licence type
351(k) biosimilar, not interchangeable
Presentations
80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials
Note
First FDA-approved tocilizumab biosimilar.
Source
S001, S016
EMA
European Union · Tocilizumab STADA
European Medicines Agency and European CommissionApprovedBrand
Tocilizumab STADA
Holder or applicant
STADA Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Jun 2024
Application or permission
EMEA/H/C/005984
Indications as licensed
RA, GCA, sJIA, pJIA, CRS, COVID-19
Presentations
see SmPC
Note
Previously named Tofidence.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDASep 2023Approved by FDA as Tofidence
- EMAJun 2024Authorised by the European Commission as Tocilizumab STADA
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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