FDA Approves Poherdy as First Interchangeable Biosimilar to Perjeta for HER2-Positive Breast Cancer

Overview

• Poherdy (pertuzumab-dpzb) is authorized for use with trastuzumab and docetaxel in untreated HER2-positive metastatic disease, as neoadjuvant therapy for select locally advanced or early-stage tumors, and as adjuvant therapy for early breast cancer at high risk of recurrence.
• The FDA’s decision followed analytical comparisons plus pharmacokinetic, immunogenicity, and clinical data, including a healthy-volunteer PK study and a neoadjuvant trial in early HER2-positive, hormone receptor–negative breast cancer.
• The prescribing information specifies an initial 840 mg intravenous infusion over 60 minutes, followed by 420 mg every three weeks over 30 to 60 minutes.
• The label carries boxed warnings for left ventricular dysfunction and embryo-fetal toxicity and notes risks of infusion-related reactions and hypersensitivity, with adverse reactions consistent with pertuzumab-containing regimens.
• Pharmacists may substitute Poherdy for Perjeta where permitted by state law, and the product is manufactured by Shanghai Henlius Biologics Co.