Shanghai Henlius Biotech and Organon Announced that the US Food and Drug Administration (FDA) has granted approval to the Biologics License Application for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use. The product, cleared as an interchangeable biosimilar to PERJETA (pertuzumab) across all reference indications, becomes the first pertuzumab biosimilar authorized in the US. With this decision, the companies point to a step forward in widening patient access to high-quality biologic options for certain HER2-positive breast cancers.
Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon said that POHERDY’s approval not only introduces the first PERJETA biosimilar in the US but also aligns with Organon’s broader effort to strengthen its women’s health and oncology biosimilars portfolio. “Our collaboration with Henlius is critical to our goal of making health care more sustainable for US patients.”
The approval of the PERJETA biosimilar covers POHERDY’s use as a HER2/neu receptor antagonist in combination with trastuzumab and docetaxel for adults diagnosed with HER2-positive metastatic breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease. Additional indications include its combined use with trastuzumab and chemotherapy for adults undergoing neoadjuvant treatment for HER2-positive, locally advanced, inflammatory, or early stage breast cancer greater than 2 cm or node positive, as well as adjuvant treatment for high-risk HER2-positive early breast cancer.
Safety information highlights the potential for pertuzumab products to cause subclinical and clinical cardiac failure, including decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Clinicians are advised to monitor cardiac function and discontinue treatment if a clinically significant decline is confirmed. The product also carries warnings regarding embryo-fetal death and birth defects and recommends effective contraception.
Regulators based their decision on a complete data package incorporating analytical comparison, clinical pharmacokinetic studies, and head-to-head clinical trials designed to show POHERDY’s high similarity and interchangeability with PERJETA in safety, purity, and potency (safety and effectiveness).
Henlius and Organon first established their partnership in 2022 through a license and supply agreement that granted Organon exclusive commercialization rights to several biosimilars, including POHERDY, in all markets except China. According to both companies, POHERDY’s FDA clearance expands their shared oncology portfolio and strengthens their ability to bring quality biologics to a broader patient population.
