Pune, India | November 14, 2025
The U.S. Food and Drug Administration (FDA) has approved Poherdy (pertuzumab‑dpzb) as the first interchangeable biosimilar to Perjeta (pertuzumab). This approval represents a significant milestone that could expand access to vital therapy for patients diagnosed with HER2-positive breast cancer. Consequently, more patients may benefit from an effective treatment option that matches the original biologic in clinical performance.
Developed by Shanghai Henlius Biologics Co., Ltd., Poherdy can be prescribed for multiple key treatment settings. Physicians can administer it alongside trastuzumab and docetaxel in adults with HER2-positive metastatic breast cancer (MBC) who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease. Furthermore, clinicians may use Poherdy as a neoadjuvant therapy in combination with trastuzumab and chemotherapy for locally advanced, inflammatory, or early-stage HER2-positive breast cancer. Additionally, it may serve as an adjuvant treatment in high-risk early breast cancer patients. It is again paired with trastuzumab and chemotherapy, supporting comprehensive care across disease stages.
The FDA based its approval on a thorough evaluation comparing Poherdy with Perjeta through structural, functional, and clinical analyses. Regulators reviewed human pharmacokinetic studies, immunogenicity data, and clinical trial outcomes. All of which confirmed that Poherdy is highly similar and clinically equivalent to Perjeta. Consequently, healthcare providers can confidently prescribe it as an alternative without compromising safety or efficacy.
However, the prescribing information includes important warnings that providers must consider. Poherdy carries a boxed warning for left ventricular dysfunction and embryo-fetal toxicity. In addition, clinicians should be vigilant for infusion-related reactions, hypersensitivity, and the potential for anaphylaxis. For the initial dose, practitioners administer 840 mg of pertuzumab-dpzb intravenously over 60 minutes. It is followed by a 420 mg maintenance dose every three weeks through a 30–60 minute infusion. Ensuring proper treatment delivery.
The FDA encourages healthcare professionals to report all serious adverse events through its MedWatch Reporting System or by calling 1‑800‑FDA‑1088. For single-patient investigational access, providers can also contact the FDA Oncology Center of Excellence’s Project Facilitate. It offers streamlined support for urgent clinical needs.
Experts highlight that this approval could enhance patient access while potentially lowering costs. Pharmacies may substitute an interchangeable biosimilar for the reference product depending on state regulations, resembling how generic drugs replace brand-name equivalents. This substitution model allows patients to access more affordable treatment without requiring prescriber approval for each refill. It potentially reduces financial burden and improves adherence.
With Poherdy now recognized as the first interchangeable biosimilar version of pertuzumab. The FDA has taken a major step in increasing biologic therapy availability. The agency emphasized its comprehensive yet efficient review process, analyzing multiple lots of both Poherdy and Perjeta across numerous quality attributes. According to FDA findings, the two medicines share highly similar structural and functional features that directly impact safety and effectiveness.
In clinical investigations, including studies in healthy volunteers and neoadjuvant breast cancer patients, Poherdy demonstrated comparable pharmacokinetics, immunogenicity, and safety to Perjeta. Considering all available evidence, regulators determined that healthcare providers can use Poherdy interchangeably in routine clinical practice, boosting confidence among providers and patients alike.
Finally, this approval may also generate economic benefits. Biosimilars typically cost less than their branded counterparts, and endorsing an interchangeable biosimilar for a leading HER2-targeted therapy could expand utilization while lowering treatment expenses. Consequently, patients with HER2-positive breast cancer may access life-saving therapy with reduced financial strain, marking a substantial advancement in oncology care.
Overall, the FDA’s approval of Poherdy underscores the agency’s commitment to rigorous evaluation while promoting accessibility and affordability. As the first interchangeable pertuzumab biosimilar, it represents a promising option for patients and clinicians, potentially reshaping treatment standards in HER2-positive breast cancer care.
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