China-based biopharmaceutical company Shanghai Henlius Biotech Inc (HK:2696) and US healthcare company Organon (NYSE:OGN) announced on Monday that the US Food and Drug Administration (FDA) has approved POHERDY (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, the first biosimilar to PERJETA (pertuzumab) available in the United States.

The approval covers all indications of the reference product.

POHERDY is indicated in combination with trastuzumab and chemotherapy for adults with HER2-positive metastatic, locally advanced, inflammatory, or early-stage breast cancer, including high-risk early breast cancer.

The FDA decision was based on analytical, pharmacokinetic, and clinical data demonstrating that POHERDY is highly similar to and interchangeable with PERJETA in terms of safety, purity, and potency (safety and effectiveness).

Henlius and Organon have an existing licence and supply agreement granting Organon exclusive global commercialisation rights for POHERDY outside China.