Poherdy (pertuzumab)
- Region
- 🇪🇺 EU
- Active substance
- pertuzumab
- Company
- Organon N.V.
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 26 Feb 2026
- EU approval
- Thu 23 Apr 2026
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006583
- ATC
- L01FD02
- Official record
- www.ema.europa.eu
Indication
Early breast cancerPoherdy is indicated for use in combination with trastuzumab and chemotherapy in:- the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence- the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrenceMetastatic breast cancerPoherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Regulatory milestones
Poherdy (pertuzumab) approved in the EU
Marketing authorisation to Organon N.V.; Biosimilar, Additional monitoring · source
Poherdy (pertuzumab): CHMP positive opinion
Organon N.V.; Biosimilar, Additional monitoring · source
FDA approves biosimilar Poherdy (pertuzumab-dpzb)
Shanghai Henlius Biotech; BLA761450; Biosimilar; injectable · source
Same substance in other markets
- 🇪🇺 Phesgo Authorised · Roche Registration GmbH
- 🇪🇺 Pebrilzo Opinion · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Perjeta Authorised · Roche Registration GmbH
- 🇺🇸 Poherdy Approved · Shanghai Henlius Biotech
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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.