Shanghai Henlius Biotech, a biopharmaceutical company developing biologics, and Organon, a healthcare company focused on addressing women’s health needs, announced FDA approval of Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Perjeta (pertuzumab) on November 17, 2025. Pertuzumab-dpzb, a HER2/neu receptor antagonist, is the first and only approved biosimilar for pertuzumab in the United States.
Pertuzumab-dpzb is now indicated for all indications of pertuzumab. This includes its use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. It is also indicated for use in combination with trastuzumab and chemotherapy for both neoadjuvant and adjuvant treatment of certain adults with early breast cancer.
According to a company press release, approval for pertuzumab-dpzb was based on a review of a comprehensive data package provided to FDA. The package consisted of data concerning its clinical similarity and interchangeability with pertuzumab, including evaluations of its analytical similarity, clinical pharmacokinetic studies, and comparative clinical studies.
“The FDA approval of [pertuzumab-dpzb] marks a significant milestone in Henlius’ global expansion and quality biologics development. As the first pertuzumab biosimilar approved in the US, this important achievement demonstrates our core capability to build a sustainable global R&D system grounded in rigorous scientific and regulatory standards. It also reflects Henlius’ steadfast commitment to its patient-centric philosophy and long-term global strategy,” said Dr. Jason Zhu, Executive Director and CEO, Henlius, in the release. “We will continue accelerating the delivery of quality biologics to benefit more patients worldwide and create greater value for human health.”
“Expanding access to treatments for diseases that disproportionately impact women, including breast cancer, the most common cancer among women in the US excluding skin cancer, is at the core of our mission,” said Jon Martin, US Commercial Lead, Biosimilars and Established Brands, Organon, in the release. “Not only is [pertuzumab-dpzb] the first approved biosimilar to [pertuzumab] in the US, but its approval also builds on Organon’s recent momentum of expanding our biosimilars portfolio in women’s health and oncology. Our collaboration with Henlius is critical to our goal of making health care more sustainable for US patients.”
Henlius and Organon entered into a license and supply agreement in 2022, granting Organon the exclusive commercial rights to multiple biosimilars, including pertuzumab-dpzb. Organon has exclusive commercial rights to pertuzumab-dpzb in all territories except China.
