Posted by Michael Wonder on 18 Nov 2025
Henlius and Organon announce US FDA approval of Poherdy (pertuzumab-dpzb), the first Perjeta (pertuzumab) biosimilar in the US
17 November 2025 - Shanghai Henlius Biotech and Organon today announced that the US FDA has approved the biologics license application 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.
