Vegzelma
Bevacizumab biosimilar developed by Celltrion, development code CT-P16. Reference product Avastin.
Brands by market: Vegzelma (USA, EU) · Commercial partner or holder: Celltrion
FDASep 2022approved
EMAAug 2022authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Vegzelma
US Food and Drug AdministrationApprovedBrand
Vegzelma
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Sep 2022
Application or permission
761268
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S001, S016
EMA
European Union · Vegzelma
European Medicines Agency and European CommissionApprovedBrand
Vegzelma
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Aug 2022
Application or permission
EMEA/H/C/005534
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAAug 2022Authorised by the European Commission as Vegzelma
- FDASep 2022Approved by FDA as Vegzelma
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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