Organon in Jersey City and Shanghai Henlius Biotech, Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Poherdy (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to Perjeta (pertuzumab), for all indications of the reference product.
Poherdy is the first and only approved pertuzumab biosimilar in the U.S., representing an important milestone in expanding access to high-quality, potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers.
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to multiple biosimilars, including Poherdy. The agreement covers exclusive global commercialization rights, except for China.
“Expanding access to treatments for diseases that disproportionately impact women, including breast cancer, the most common cancer among women in the U.S., excluding skin cancer, is at the core of our mission,” said Jon Martin, U.S. commercial lead, biosimilars and established brands at Organon.
“Not only is Poherdy the first approved biosimilar to Perjeta in the U.S., 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 U.S. patients.”
“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 U.S., this important achievement demonstrates our core capability to build a sustainable global R&D system grounded in rigorous scientific and regulatory standards.”
The FDA approval of Poherdy will further enhance the partners’ oncology portfolio and their ability to deliver quality biologics to more patients.
