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
FDAJan 2025approved
EMAFeb 2025authorised
CDSCOnot listed
EDEnot listed
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
Presentations
80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials; 162 mg/0.9 mL SC (BLA 761498)
Note
Interchangeable on licensure for both presentations.
Source
S001, S016
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAJan 2025Approved by FDA as Avtozma
- EMAFeb 2025Authorised by the European Commission 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)
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