On November 17, Organon and its China-based partner Henlius announced that the FDA has approved the first pertuzumab biosimilar. The Perjeta biosimilar was dubbed Poherdy (pertuzumab-dpzb).
Poherdy is approved for use for all of the indications of the reference product Perjeta (manufacturer, Roche). Pertuzumab is an HER2/neu-receptor agonist that is used in combination with trastuzumab and docetaxel for the treatment of HER2-positive metastatic breast cancer in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer. This first pertuzumab biosimilar is also indicated for use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. Additionally, Poherdy can be used as adjuvant treatment in patients with HER2-positive early-stage breast cancer that has a high risk of recurrence.
Jon Martin, Organon’s US Commercial Lead, Biosimilars and Established Brands, stated in a press release, “Not only is Poherdy the first Perjeta biosimilar approved 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.”
Organon and Henlius signed an agreement in 2022 granting Organon exclusive commercial rights to several Henlius-developed biosimilars in the US. In 2024, Roche announced Perjeta net sales of $1.69 billion, about 3% greater than in prior year.
Formerly designated HLX11, Poherdy leads several pertuzumab biosimilar candidates seeking to launch. Organon did not announce a launch date or pricing for the product; we assume that launch of Poherdy will take place in 2026. The main patent for the reference product expired in 2024, and four other manufacturers have publicly disclosed potential biosimilar candidates in this category.
