On November 13, 2025, the US Food and Drug Administration approved pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to pertuzumab (Perjeta) for the treatment of HER2-positive breast cancer, consistent with the indications of the reference product.

The approval was based on analytical, nonclinical, and clinical data establishing biosimilarity and interchangeability with the reference product. Evidence included a pharmacokinetic study and a comparative clinical trial in patients with HER2-positive breast cancer, demonstrating no clinically meaningful differences in safety, purity, or potency.

No new safety signals were observed. The safety profile of pertuzumab-dpzb is expected to reflect that of pertuzumab, with common adverse reactions including diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. Serious risks include left ventricular dysfunction and infusion-related reactions.

Pertuzumab-dpzb is the first interchangeable biosimilar to pertuzumab approved in the United States. The interchangeable designation permits pharmacy-level substitution, where state law allows, and may increase access while reducing treatment costs for patients with HER2-positive breast cancer.

Reference
US Food and Drug Administration. FDA approves new interchangeable biosimilar to Perjeta. Published November 13, 2025. Accessed November 18, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta