Organon announces FDA approval for Poherdy BLA

Shanghai Henlius Biotech and Organon (OGN) announced that the FDA has approved the biologics license application for Poherdy 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to Perjeta, for all indications of the reference product. Poherdy is the first and only approved pertuzumab biosimilar in the U.S.