Vegzelma
Bevacizumab biosimilar developed by Celltrion, development code CT-P16. Reference product Avastin.
Brands by market: Vegzelma (USA, EU) · Commercial partner or holder: Celltrion · Company profile
FDASep 2022approved
EMAAug 2022authorised
MHRALicenseddate not shown
PMDASep 2022approved
HCJan 2023approved
CDSCONot listed
EDENot listed
Approved or registered in 5 of 7 markets
Connections
About Vegzelma
Vegzelma is Celltrion's bevacizumab, approved in Europe and the United States within weeks of each other in 2022, in Japan the same month under the Nippon Kayaku partnership, and in Canada in early 2023. It completed Celltrion's set of the three major cancer antibodies after trastuzumab and rituximab.
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
Reference product in the Purple Book
Avastin
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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 (EMA) · checked Sep 2026
MHRA
United Kingdom · Vegzelma
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Vegzelma
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
25 mg/mL vials
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Bevacizumab BS CTNK
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Bevacizumab BS CTNK
Holder or applicant
Nippon Kayaku (Celltrion)
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2022
Indications as licensed
Colorectal cancer, non-squamous NSCLC, breast cancer
Presentations
100 mg and 400 mg vials
Remarks
Bevacizumab Biosimilar 4.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Vegzelma
Health CanadaApprovedBrand
Vegzelma
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jan 2023
Application or permission
DIN 02534177, 02534185
Presentations
100, 400 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Vegzelma by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| CT-P16 | Celltrion | Avastin | Phase 1 | Comparative PK | Completed | Aug 2017 | Dec 2017 | NCT03247673 |
Other developers in the same markets
Where Vegzelma holds an approval, these are the other bevacizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Amgen (Mvasi), Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Pfizer (Zirabev), mAbxience (Alymsys / Oyavas) |
| EMA | 6 | Amgen (Mvasi), Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Pfizer (Zirabev), Samsung Bioepis (Aybintio), mAbxience (Alymsys / Oyavas) |
| MHRA | 5 | Biocon Biologics (Jobevne / Abevmy / Krabeva), Not stated in the MHRA list (Versavo), Pfizer (Zirabev), Samsung Bioepis (Aybintio), mAbxience (Alymsys / Oyavas) |
| PMDA | 3 | Amgen (Mvasi), Nichi-Iko Pharmaceutical (Bevacizumab BS Nichi-Iko), Pfizer (Zirabev) |
| HC | 5 | Amgen (Mvasi), Apotex (Bambevi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Pfizer (Zirabev), Samsung Bioepis (Aybintio) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Celltrion: Avtozma, Eydenzelt, Herzuma, Omlyclo, Remsima / Inflectra, Steqeyma, Stoboclo / Osenvelt, Truxima / Blitzima, Yuflyma.
Chronology
- EMAAug 2022Authorised by the European Commission as Vegzelma
- PMDASep 2022Approved by MHLW as Bevacizumab BS CTNK
- FDASep 2022Approved by FDA as Vegzelma
- HCJan 2023Notice of Compliance, Health Canada 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)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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