Home/Biosimilar Atlas/Tocilizumab/Tyenne

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 · Company profile
FDAMar 2024approved
EMASep 2023authorised
MHRALicenseddate not shown
PMDANot listed
HCOct 2024approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
TocilizumabmoleculeFresenius Kabideveloper4 of 7markets0trials behind it4other products, same developer3rival developers in its markets

About Tyenne

Tyenne is Fresenius Kabi's tocilizumab, the first tocilizumab biosimilar approved in Europe, in September 2023. The United States approved the infusion form in March 2024 and the under-the-skin form a year later, and Canada approved it in 2024. It was the first tocilizumab biosimilar in either form to reach the US market.

Status by market

FDA

United States · Tyenne

US Food and Drug AdministrationApproved
Brand
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
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; 162 mg/0.9 mL SC (BLA 761449, March 2025)
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Tyenne

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
First EU tocilizumab biosimilar.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Tyenne

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Tyenne
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
162 mg syringe and pen; 20 mg/mL concentrate
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada · Tyenne

Health CanadaApproved
Brand
Tyenne
Holder or applicant
Fresenius Kabi Canada LTD
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Oct 2024
Application or permission
DIN 02552450, 02552469, 02552477, 02552485, 02552493
Presentations
162, 200, 400, 80 mg
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 Tyenne holds an approval, these are the other tocilizumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA2Bio-Thera Solutions (Tofidence / Tocilizumab STADA), Celltrion (Avtozma)
EMA3Bio-Thera Solutions (Tofidence / Tocilizumab STADA), Celltrion (Avtozma), Gedeon Richter (Tuyory)
MHRA3Bio-Thera Solutions (Tofidence / Tocilizumab STADA), Celltrion (Avtozma), Gedeon Richter (Tuyory)
HC1Celltrion (Avtozma)

Same developer, other molecules

Other biosimilars in the Atlas developed by Fresenius Kabi: Conexxence / Bomyntra, Elonox, Idacio, Stimufend.

Chronology

Sources

All tocilizumab biosimilars

Planning tocilizumab biosimilar development?

EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.

Talk to a biosimilar regulatory consultant
Data current to September 2026.