Shanghai Henlius Biotech, Inc., and Organon announced that the US Food and Drug Administration has approved the Biologics License Application (BLA) for POHERDY 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to PERJETA , for all indications of the reference product. POHERDY is the first and only approved pertuzumab biosimilar in the US, representing an important milestone in expanding access to quality and potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers.
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“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. Our collaboration with Henlius is critical to our goal of making health care more sustainable for US patients.”
“The FDA approval of POHERDY 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 Chief Executive Officer of Henlius. “We will continue accelerating the delivery of quality biologics to benefit more patients worldwide and create greater value for human health.”
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“The approval of POHERDY further underscores Henlius’ track record in international registration, together with our strength in quality management and commercialization collaboration,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “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.”
POHERDY is a HER2/neu receptor antagonist indicated for 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. POHERDY is also indicated for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
Pertuzumab products can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue POHERDY treatment for a confirmed clinically significant decrease in left ventricular function. Exposure to pertuzumab products can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception.
POHERDY was approved based on the review of a comprehensive data package, which includes analytical similarity, clinical pharmacokinetic studies, and comparative clinical studies demonstrating that POHERDY is highly similar to and interchangeable with the reference product PERJETA in terms of safety, purity, and potency (safety and effectiveness).
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. The FDA approval of POHERDY will further enhance the partners’ oncology portfolio and their ability to deliver quality biologics to more patients.
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Source- businesswire
