The US Food and Drug Administration has approved POHERDY (pertuzumab-dpzb), developed by Henlius and commercialized by Organon, as the first biosimilar to PERJETA (pertuzumab) in the United States. The approval covers all indications of the reference product for treating HER2-positive breast cancer.
POHERDY is approved as an interchangeable biosimilar for use in combination with trastuzumab and chemotherapy for treating adults with HER2-positive metastatic breast cancer, as well as for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer.
“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 at Organon. “Not only is POHERDY the first approved biosimilar to PERJETA in the US, but its approval also builds on Organon’s recent momentum of expanding our biosimilars portfolio in women’s health and oncology.”
The approval was based on a comprehensive data package including analytical similarity, clinical pharmacokinetic studies, and comparative clinical studies demonstrating that POHERDY is highly similar to and interchangeable with PERJETA in terms of safety, purity, and potency.
“The FDA approval of POHERDY marks a significant milestone in Henlius’ global expansion and quality biologics development,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “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.”
POHERDY can cause left ventricular dysfunction and embryo-fetal toxicity. The drug can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction and congestive heart failure. Exposure to pertuzumab products can cause embryo-fetal death and birth defects.
In 2022, Henlius entered into a license and supply agreement with Organon granting exclusive commercialization rights to multiple biosimilars including POHERDY, covering global markets except China.
“We look forward to working closely with our partner Organon to leverage our complementary strengths in supply chain, market, and distribution networks, jointly enhancing access to quality biologics and providing patients with treatment options that combine quality and affordability,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius.
Henlius is a global biopharmaceutical company based in Shanghai with 10 products approved for marketing across multiple countries and regions.
