Zydus bevacizumab
Bevacizumab biosimilar developed by Cadila Healthcare (Zydus Lifesciences). Reference product Avastin.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Zydus Lifesciences
FDAnot listed
EMAnot listed
CDSCOMay 2017permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Cadila Healthcare Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
May 2017
Application or permission
MF-097/2017; additional strength MF/BIO/25/000160
Indications as licensed
Colorectal, NSCLC, renal and other solid tumours
Presentations
100 mg/4 mL and 400 mg/16 mL
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMay 2017CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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