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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) · Company profile
FDASep 2023approved
EMAJun 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
TocilizumabmoleculeBio-Thera Solutionsdeveloper3 of 7markets0trials behind it2other products, same developer3rival developers in its markets

About Tofidence / Tocilizumab STADA

Tofidence was the first tocilizumab biosimilar approved in the United States, in September 2023, developed by Bio-Thera Solutions of China and sold by Biogen. It is an infusion only. In Europe the same product was approved in 2024 and is sold by Stada under the name Tocilizumab STADA, having originally been called Tofidence there too.

Status by market

FDA

United States · Tofidence

US Food and Drug AdministrationApproved
Brand
Tofidence
Holder or applicant
Biogen MA Inc.
Pathway
351(k)
Approved
Sep 2023
Application or permission
761354
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Actemra
Marketing status (Purple Book)
Prescription, marketed
Presentations
80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials
Remarks
First FDA-approved tocilizumab biosimilar.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Tocilizumab STADA

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
Previously named Tofidence.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Tofidence

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Tofidence
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
20 mg/mL concentrate
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Tofidence / Tocilizumab STADA holds an approval, these are the other tocilizumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA2Celltrion (Avtozma), Fresenius Kabi (Tyenne)
EMA3Celltrion (Avtozma), Fresenius Kabi (Tyenne), Gedeon Richter (Tuyory)
MHRA3Celltrion (Avtozma), Fresenius Kabi (Tyenne), Gedeon Richter (Tuyory)

Same developer, other molecules

Other biosimilars in the Atlas developed by Bio-Thera Solutions: Avzivi, Starjemza.

Chronology

Sources

All tocilizumab biosimilars

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Data current to September 2026.