Pune, India | November 14, 2025
The U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumabâdpzb) as the first interchangeable biosimilar to Perjeta (pertuzumab). This landmark approval could expand access to a critical therapy for patients with HER2-positive breast cancer.
Shanghai Henlius Biologics Co., Ltd. developed Poherdy, and doctors can use it for several key purposes. Physicians can administer it with trastuzumab and docetaxel to adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. In addition, doctors can prescribe Poherdy as a neoadjuvant treatment combined with trastuzumab and chemotherapy. For locally advanced, inflammatory, or early-stage HER2-positive breast cancer. Finally, it may be used as an adjuvant treatment in high-risk early breast cancer patients, again together with trastuzumab and chemotherapy.
The FDA’s approval rested on a comprehensive comparison of Poherdy with Perjeta, spanning structural, functional, and clinical data. Regulators reviewed human pharmacokinetic studies, immunogenicity data, and clinical trial results, all of which supported that Poherdy is highly similar and clinically no different from Perjeta.
Yet, the prescribing information does carry important warnings. Pheredy has a boxed warning for left ventricular dysfunction and embryoâfetal toxicity. Additional precautions include possible infusion-related reactions, hypersensitivity, and the risk of anaphylaxis.
For the initial dose, healthcare providers administer 840 mg of pertuzumabâdpzb intravenously over 60 minutes. Afterward, they give a maintenance dose of 420 mg every three weeks via a 30–60 minute IV infusion.
Healthcare professionals are encouraged to report all serious adverse events to the FDA’s MedWatch Reporting System, or call 1â800âFDAâ1088. For support with single-patient investigational access, providers may also reach out to the FDA Oncology Center of Excellence’s Project Facilitate.
Experts say this approval could improve patient access and potentially drive down costs. Pharmacies may substitute an interchangeable biosimilar for the reference product, depending on state laws. This substitution model resembles how pharmacies replace generic drugs. It offers a more affordable option without the need to consult the prescriber each time.
With this decision, Poherdy becomes the first interchangeable biosimilar version of pertuzumab, marking a major step forward in the FDA’s efforts to increase the availability of biologic therapies.
The FDA’s approval of Poherdy underscores its rigorous but efficient review process. The agency evaluated multiple product lots of both Poherdy and Perjeta across a wide range of quality attributes. According to the FDA, these analyses confirmed that the two medicines share highly similar structural and functional features known to affect safety and efficacy.
In clinical studies, including healthy volunteer pharmacokinetics trials and patient studies in the neoadjuvant breast cancer setting, Poherdy showed comparable exposure, immunogenicity, and safety to Perjeta. With all of the evidence considered, regulators concluded that Poherdy can be used interchangeably.
Finally, this approval may deliver economic benefits. Biosimilars often cost less than their brand-name counterparts. By endorsing an interchangeable biosimilar for a leading HER2-targeted therapy, the FDA has potentially opened the door to wider uptake and reduced treatment costs for patients battling HER2-positive breast cancer.
