First Biosimilar for Pertuzumab Approved for HER2-positive Breast Cancer
The FDA approved pertuzumab-dpzb for interchangeable use with pertuzumab.
The U.S. Food and Drug Administration (FDA) has approved pertuzumab-dpzb (Poherdy) as a biosimilar to pertuzumab (Perjeta) for certain adults with HER2-positive breast cancer. Pertuzumab-dpzb may be used in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received anti-HER2 therapy or chemotherapy in the metastatic setting. Pertuzumab-dpzb may also be used in combination with trastuzumab and chemotherapy for adults with HER2-positive breast cancer that is either locally advanced, inflammatory, or early-stage; or as an adjuvant treatment for adults with HER2-positive early breast cancer that has a high risk of recurrence.
Pertuzumab-dpzb can be used interchangeably with the drug pertuzumab because the two are biosimilar—meaning that their structures and activity are highly similar with no clinically meaningful differences in safety or efficacy. Both drugs are monoclonal antibodies that target the HER2 receptor to disrupt critical cell signaling and induce cell death.
The approval of pertuzumab-dpzb marks the first approval of a biosimilar for pertuzumab, which has been approved since 2012 to treat certain HER2-positive breast cancers.
The approval was based on a review of evidence that found that pertuzumab-dpzb had highly similar structure, function, and pharmacokinetic properties as pertuzumab, including similar exposure to the drug after a single intravenous infusion. This conclusion was based on safety and efficacy data, human pharmacokinetic data, clinical immunogenicity data, and supportive clinical data. The review was a part of the FDA’s abbreviated approval pathway for biosimilars.
The prescribing information for pertuzumab-dpzb includes a boxed warning for two serious side effects: left ventricular dysfunction in the heart, which can lead to heart failure, and embryo-fetal toxicity that can cause birth defects and/or embryo-fetal death. Per the warnings, the FDA advises clinicians to evaluate cardiac function before and during treatment. Patients receiving pertuzumab-dpzb are recommended to use effective contraception during treatment and for seven months following their last dose.
The recommended dose for pertuzumab-dpzb is 840 mg, infused for one hour, followed every three weeks thereafter by a 420 mg intravenous infusion for 30 to 60 minutes.
Breast cancer is the most common form of non-skin cancer. Approximately 13% of breast cancers are considered HER2-positive, meaning they express abnormally high levels of this protein. According to federal statistics, it was estimated that 316,950 individuals would be diagnosed with breast cancer and 42,170 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on November 13, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.