FDA Approves first Interchangeable Biosimilar to Perjeta (pertuzumab)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761450s000lbl.pdf?utm_medium=email&utm_source=govdelivery On November 11, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Perjeta (pertuzumab). This is the first approval of a biosimilar for Perjeta. A biosimilar product is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference product. As a biosimilar product, Poherdy can be used in place of Perjeta. As an interchangeable biosimilar, Poherdy may be substituted at the pharmacy for the reference product, depending on state laws. Poherdy is a HER2/neu receptor antagonist indicated for the treatment of HER2-positive metastatic, locally advanced, inflammatory, and early-stage breast cancer. Poherdy is used in combination with trastuzumab and docetaxel or chemotherapy depending on the indication. The prescribing information includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, and warnings and precautions for infusion-related reactions and hypersensitivity reactions/anaphylaxis. Full prescribing information for Poherdy can be found on Drugs@FDA.  The approval was based on comparisons across a broad range of structural and functional product quality attributes, including those known to impact safety and efficacy, human pharmacokinetic data, clinical immunogenicity data, and supportive clinical data in patients with breast cancer demonstrating that Poherdy is biosimilar to and interchangeable with Perjeta. Poherdy (pertuzumab-dpzb) is the 78th biosimilar product approved in the U.S for the 20th unique reference product. The availability of biosimilar and interchangeable products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients.