Pune, India | November 14, 2025
The U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb) as the inaugural interchangeable biosimilar to Perjeta (pertuzumab). This historic approval is poised to significantly improve access to key therapies for individuals diagnosed with HER2-positive breast cancer.
Shanghai Henlius Biologics Co., Ltd. developed Poherdy, and FDA clearance enables physicians to utilize this biosimilar in several pivotal breast cancer scenarios. For adults managing HER2-positive metastatic breast cancer (MBC) who haven’t previously received anti-HER2 or chemotherapy for metastatic disease. The medical professionals may combine Poherdy with trastuzumab and docetaxel.
Furthermore, clinicians use Poherdy as a neoadjuvant treatment—alongside trastuzumab and chemotherapy—to target locally advanced, inflammatory, or early-stage HER2-positive breast cancer. Clinicians can also rely on Poherdy as an adjuvant therapy for high-risk early breast cancer patients. It is again pairing it with trastuzumab and chemotherapy.
An exhaustive analysis comparing Poherdy with Perjeta—encompassing extensive structural examinations and functional evaluations—underpinned the FDA’s landmark approval. Regulators scrutinized a broad range of product lots using an array of analytical tests and biological assays, which revealed that the biosimilar shares highly similar qualities with the reference product in terms of safety and efficacy.
Clinical studies, including pharmacokinetic trials with healthy volunteers and research involving breast cancer patients in neoadjuvant settings. It confirmed Poherdy’s comparable exposure, immunogenicity, and safety profile to Perjeta. Consequently, the FDA found Poherdy to be interchangeable.
Even so, the prescribing guidelines for Poherdy contain essential warnings. The drug carries a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, flagging significant risks for specific patient groups. Additional advisories highlight potential infusion-related reactions, hypersensitivity, and the risk of anaphylaxis. The initial administration consists of an 840 mg intravenous infusion over 60 minutes, followed by maintenance doses of 420 mg every three weeks, each delivered over 30–60 minutes.
Healthcare providers are strongly encouraged to report all serious adverse events via the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. Should providers need support for single-patient investigational access, they can contact the FDA’s Oncology Center of Excellence through Project Facilitate.
Experts anticipate that the approval of Poherdy can expand patient access and potentially lower treatment costs for HER2-positive breast cancer. Pharmacies may substitute an interchangeable biosimilar like Poherdy in place of Perjeta, depending on the rules of each state. This model echoes the approach to generic drug substitution, and could benefit patients by streamlining access to lower-cost therapies.
Poherdy’s status as the first interchangeable biosimilar for pertuzumab marks a milestone in expanding the FDA’s biologic therapy portfolio. The agency’s exhaustive review included multiple batches of both products, confirming their similarity across extensive product attributes. According to the FDA, these standards ensure both safety and effectiveness for patients relying on either medication.
Due to biosimilars like Poherdy costing less than their brand-name counterparts, patient access to HER2-targeted treatments may further increase. Since FDA approval signals no clinical difference between Poherdy and Perjeta, this decision aligns with ongoing efforts to make high-quality cancer therapies more affordable.
Ultimately, the FDA’s rigorous and efficient process has ushered in greater choices for HER2-positive breast cancer care, guaranteeing that Poherdy stands as a truly interchangeable and cost-effective option for thousands of patients in need.
