Intas pertuzumab
Pertuzumab biosimilar developed by Intas Pharmaceuticals. Reference product Perjeta.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Intas Pharmaceuticals
FDAnot listed
EMAnot listed
CDSCOJan 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
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2025
Application or permission
MF/BIO/25/000006; additional indication MF/BIO/26/000006 (February 2026)
Indications as licensed
HER2-positive metastatic breast cancer; neoadjuvant early breast cancer added February 2026
Presentations
420 mg/14 mL (30 mg/mL) vial
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJan 2025CDSCO permission granted
Sources
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