Poherdy (pertuzumab-dpzb)
Biosimilar
- Region
- 🇺🇸 US
- Active substance
- pertuzumab-dpzb
- Company
- Shanghai Henlius Biotech
- Status
- Approved
- FDA approval
- Thu 13 Nov 2025
- Designations
- Biosimilar
- Application
- BLA761450
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Thu 23 Apr 2026🇪🇺 EU approval (EC decision)
Poherdy (pertuzumab) approved in the EU
Marketing authorisation to Organon N.V.; Biosimilar, Additional monitoring · source
Thu 26 Feb 2026🇪🇺 CHMP positive opinion
Poherdy (pertuzumab): CHMP positive opinion
Organon N.V.; Biosimilar, Additional monitoring · source
Thu 13 Nov 2025🇺🇸 FDA approval
FDA approves biosimilar Poherdy (pertuzumab-dpzb)
Shanghai Henlius Biotech; BLA761450; Biosimilar; injectable · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.