Shanghai Henlius Biotech, Inc. and Organon announced that the US 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 US, representing an important milestone in expanding access to quality and potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers. 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. See full indications below.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.
See additional safety information below. 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.
