Enzene Biosciences pertuzumab
Pertuzumab biosimilar developed by Enzene Biosciences (Alkem). Reference product Perjeta.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Enzene Biosciences
FDAnot listed
EMAnot listed
CDSCOJun 2025permitted
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
Enzene Biosciences Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2025
Application or permission
MF/BIO/25/000085
Indications as licensed
HER2-positive metastatic breast cancer
Presentations
420 mg/14 mL (30 mg/mL) vial
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2025CDSCO permission granted
Sources
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