FDA Approves Organon and Henlius' POHERDY as First Perjeta Biosimilar in US

Reuters11-17

FDA Approves Organon and Henlius' POHERDY as First Perjeta Biosimilar in US

Organon & Co. and Shanghai Henlius Biotech, Inc. have announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for POHERDY® (pertuzumab-dpzb), an interchangeable biosimilar to PERJETA (pertuzumab). POHERDY is the first and only approved pertuzumab biosimilar in the US and is indicated for all uses of the reference product, expanding access to potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers. This approval follows an agreement between Henlius and Organon granting Organon exclusive global commercialization rights to POHERDY, except in China.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Organon & Co. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251117955804) on November 17, 2025, and is solely responsible for the information contained therein.

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