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.
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