Poherdy
Pertuzumab biosimilar developed by Shanghai Henlius Biotech, development code HLX11. Reference product Perjeta.
About Poherdy
Poherdy is Henlius's pertuzumab, sold by Organon, and the first pertuzumab biosimilar approved outside India. The United States approved it in November 2025 as interchangeable from the start, and Europe in April 2026. It follows Henlius's trastuzumab, sold as Hercessi and Zercepac, so the two HER2 antibodies used together now both have a Henlius biosimilar.
Status by market
United States · Poherdy
US Food and Drug AdministrationApprovedEuropean Union · Poherdy
European Medicines Agency and European CommissionApprovedUnited Kingdom · Poherdy
Medicines and Healthcare products Regulatory AgencyApprovedJapan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Poherdy 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 |
|---|---|---|---|---|---|---|---|---|
| HLX11 | Shanghai Henlius Biotech | Perjeta | Phase 3 | Comparative efficacy | Active, not recruiting | Apr 2022 | May 2024 | NCT05346224 |
Same developer, other molecules
Other biosimilars in the Atlas developed by Shanghai Henlius Biotech: Bildyos / Bilprevda, Hercessi / Zercepac.
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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