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The FDA approved Poherdy as the first interchangeable biosimilar to Perjeta for patients with HER2-positive breast cancer.
The U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb) as the first interchangeable biosimilar to Perjeta (pertuzumab) for patients with HER2-positive breast cancer, according to a release from the regulatory agency, marking a significant step in expanding access to HER2-targeted therapies.
The American Cancer Society explains that a biosimilar is a more affordable version of an existing biologic drug, including those used in cancer treatment. While biosimilars are not exact replicas of the original therapy, they are highly similar and must meet the FDA’s rigorous requirements to ensure they are just as safe and effective. This helps expand patient access to essential treatments and lowers overall healthcare costs.
Poherdy is a HER2/neu receptor antagonist indicated for three primary uses: in combination with Herceptin (trastuzumab) and docetaxel for adults with HER2-positive metastatic breast cancer who have not previously received chemotherapy or anti-HER2 therapy for metastatic disease; as neoadjuvant therapy with Herceptin and chemotherapy for adults with locally advanced, inflammatory, or early-stage HER2-positive breast cancer larger than 2 centimeters or node-positive; and as adjuvant therapy for adults with early-stage HER2-positive breast cancer at high risk of recurrence.
The FDA approval of Poherdy was supported by a robust set of data comparing it to Perjeta across a range of attributes, including factors influencing safety and efficacy, according to the regulatory release. Clinical evaluations demonstrated that Poherdy and Perjeta share equivalent pharmacokinetics, immunogenicity, and clinical performance in patients with breast cancer, confirming interchangeability.
Adjuvant therapy: treatment given after the main treatment (like surgery) to kill any remaining cancer cells and lower the chance of the cancer coming back.
Neoadjuvant therapy: treatment given before the main treatment (like surgery) to shrink the tumor, making it easier to remove or treat.
Poherdy’s approval builds upon extensive research conducted in prior phase 3 trials evaluating Perjeta-containing regimens in different breast cancer settings. The CLEOPATRA study investigated Perjeta in combination with Herceptin and docetaxel as first-line treatment for patients with previously untreated HER2-positive metastatic breast cancer, according to the study’s ClinicalTrials.gov page.
In CLEOPATRA, participants were randomly assigned to receive either Perjeta or placebo alongside Herceptin and docetaxel every three weeks. Treatment continued until disease progression, unacceptable toxicity, or study termination. Participants receiving placebo were not permitted to switch to Perjeta unless the predefined survival benefit criteria were achieved, the trial page continued.
Additional evidence supporting Perjeta’s benefit came from another phase 3, randomized, double-blind study evaluating its role in combination with chemotherapy and Herceptin as adjuvant therapy for patients with operable HER2-positive primary breast cancer, according to information from the APHINITY trial.
Conducted in collaboration with the Breast International Group, this study assessed the safety and efficacy of adding Perjeta to standard therapy in reducing recurrence risk following surgery. Together, these clinical findings helped establish the therapeutic relevance of Perjeta formulations such as Poherdy across multiple stages of HER2-positive disease.
Poherdy carries a boxed warning regarding potential left ventricular dysfunction and embryo-fetal toxicity, similar to other HER2-targeted agents, according to the FDA release. Additional warnings include the possibility of infusion-related reactions and hypersensitivity or anaphylaxis. Patients receiving Poherdy should be closely monitored for cardiac function and infusion-related side effects during treatment.
The recommended initial dose of Poherdy is 840 milligrams (mg) administered as a 60-minute intravenous infusion, followed every three weeks by a 420 mg dose infused over 30 to 60 minutes. Full prescribing information will be made available through the FDA Drug database to assist clinicians and patients in understanding appropriate use and safety considerations.
For patients with HER2-positive breast cancer, Poherdy’s approval represents a major step toward broadening access to advanced targeted treatments. As an interchangeable biosimilar, Poherdy can be substituted for Perjeta without the need for prescriber intervention, potentially increasing affordability and treatment availability for individuals living with HER2-positive breast cancer, the release emphasized.
With multiple approved indications across metastatic, neoadjuvant, and adjuvant settings, Poherdy provides patients and clinicians with a potential new option to support individualized treatment strategies for HER2-positive breast cancer.
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