FDA Approves Poherdy as First Interchangeable Biosimilar to Perjeta, 420 mg for HER2-Positive Breast Cancer
On November 13, the U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Genentech's Perjeta (pertuzumab). It is the first biosimilar approved for Perjeta.
Poherdy is a HER2/neu receptor antagonist supplied as a 420 mg/14 mL (30 mg/mL) single-dose vial for intravenous injection. It is approved for the same indications as the reference product in HER2-positive breast cancer, in both metastatic and early-stage settings, including use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
The FDA said the approval was based on comparisons across a broad range of structural and functional product quality attributes, human pharmacokinetic data, clinical immunogenicity data, and supportive clinical data in patients with breast cancer demonstrating that Poherdy is biosimilar to and interchangeable with Perjeta. Its prescribing information includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, and warnings and precautions for infusion-related reactions and hypersensitivity reactions/anaphylaxis. Under a 2022 license and supply agreement, Organon holds exclusive commercialization rights for Poherdy outside China.
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图中是美国食品药品管理局（FDA）总部入口。Wikimedia Commons / U.S. Food and Drug Administration, Public domain
