On November 13, 2025, the U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics) as the first interchangeable biosimilar to Perjeta (pertuzumab, Genentech). This marks a historic step in expanding HER2-targeted therapy access through biosimilar innovation.
Indications
Poherdy is a HER2/neu receptor antagonist approved for:
- In combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy.In combination with trastuzumab and chemotherapy as neoadjuvant treatment for HER2-positive locally advanced, inflammatory, or early-stage breast cancer.As adjuvant treatment for HER2-positive early breast cancer at high risk of recurrence.
Scientific Basis for Approval
The FDA’s decision was supported by a comprehensive analytical and clinical data package demonstrating similarity in structural, functional, pharmacokinetic, and immunogenicity profiles between Poherdy and Perjeta. The results confirm their comparable safety, efficacy, and interchangeability.
Dosage and Safety
The recommended initial dose is 840 mg IV infusion over 60 minutes, followed by 420 mg IV every 3 weeks over 30–60 minutes.
The label includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, along with precautions for infusion-related and hypersensitivity reactions.
Significance of the Approval
This marks the first biosimilar approval for Perjeta and a major milestone for global biosimilar development. As a China-developed biologic, Poherdy’s approval signals increasing international recognition of diversified biomanufacturing and the growing role of biosimilars in oncology cost containment.
This article was produced by the Morningglorysciences Editorial Team.
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