Avtozma
Tocilizumab biosimilar developed by Celltrion, development code CT-P47. Reference product Actemra (RoActemra in the European Union).
Brands by market: Avtozma (USA, EU) · Commercial partner or holder: Celltrion · Company profile
FDAJan 2025approved
EMAFeb 2025authorised
MHRALicenseddate not shown
PMDASep 2025approved
HCOct 2025approved
CDSCONot listed
EDENot listed
Approved or registered in 5 of 7 markets
Connections
About Avtozma
Avtozma is Celltrion's tocilizumab, approved in the United States in January 2025 in both infusion and under-the-skin forms and interchangeable for both from the start, the only tocilizumab biosimilar with that status. Europe approved it in February 2025, Japan in September, where it was the first tocilizumab biosimilar, and Canada in October.
Status by market
FDA
United States · Avtozma
US Food and Drug AdministrationApprovedBrand
Avtozma
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Jan 2025
Application or permission
761420
Licence type
351(k) interchangeable, designated Jan 2025
Reference product in the Purple Book
Actemra
Marketing status (Purple Book)
Prescription, marketed
First-interchangeable exclusivity expiry
Jul 2026
Presentations
80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials; 162 mg/0.9 mL SC (BLA 761498)
Remarks
Interchangeable on licensure for both presentations.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union · Avtozma
European Medicines Agency and European CommissionApprovedBrand
Avtozma
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/006196
Indications as licensed
RA, GCA, sJIA, pJIA, CRS, COVID-19
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Avtozma
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Avtozma
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 · Tocilizumab BS CT
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Tocilizumab BS CT
Holder or applicant
Celltrion Healthcare Japan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2025
Indications as licensed
RA, pJIA, sJIA, Castleman’s disease, CRS; SC for RA
Presentations
80 mg, 200 mg and 400 mg IV; 162 mg syringe and auto-injector
Remarks
Tocilizumab Biosimilar 1, the first in Japan.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Avtozma
Health CanadaApprovedBrand
Avtozma
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Oct 2025
Application or permission
DIN 02562022, 02562030, 02562049, 02562057, 02562065
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 Avtozma holds an approval, these are the other tocilizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 2 | Bio-Thera Solutions (Tofidence / Tocilizumab STADA), Fresenius Kabi (Tyenne) |
| EMA | 3 | Bio-Thera Solutions (Tofidence / Tocilizumab STADA), Fresenius Kabi (Tyenne), Gedeon Richter (Tuyory) |
| MHRA | 3 | Bio-Thera Solutions (Tofidence / Tocilizumab STADA), Fresenius Kabi (Tyenne), Gedeon Richter (Tuyory) |
| PMDA | 1 | Mochida Pharmaceutical (Tocilizumab BS MA) |
| HC | 1 | Fresenius Kabi (Tyenne) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Celltrion: Eydenzelt, Herzuma, Omlyclo, Remsima / Inflectra, Steqeyma, Stoboclo / Osenvelt, Truxima / Blitzima, Vegzelma, Yuflyma.
Chronology
- FDAJan 2025Approved by FDA as Avtozma
- EMAFeb 2025Authorised by the European Commission as Avtozma
- PMDASep 2025Approved by MHLW as Tocilizumab BS CT
- HCOct 2025Notice of Compliance, Health Canada as Avtozma
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)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) 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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