Poherdy
Pertuzumab biosimilar developed by Shanghai Henlius Biotech, development code HLX11. Reference product Perjeta.
Brands by market: Poherdy (USA, EU) · Commercial partner or holder: Organon (USA, EU)
FDANov 2025approved
EMAApr 2026authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Poherdy
US Food and Drug AdministrationApprovedBrand
Poherdy
Holder or applicant
Shanghai Henlius Biotech, Inc.
Pathway
351(k)
Approved
Nov 2025
Application or permission
761450
Licence type
351(k) interchangeable, designated Nov 2025
Presentations
420 mg/14 mL vial
Note
First pertuzumab biosimilar; interchangeable on licensure.
Source
S001, S016
EMA
European Union · Poherdy
European Medicines Agency and European CommissionApprovedBrand
Poherdy
Holder or applicant
Organon N.V.
Pathway
Centralised (Article 10(4))
Approved
Apr 2026
Application or permission
EMEA/H/C/006583
Indications as licensed
Early and metastatic HER2-positive breast cancer
Presentations
see SmPC
Note
First EU pertuzumab biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDANov 2025Approved by FDA as Poherdy
- EMAApr 2026Authorised by the European Commission as Poherdy
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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