FDA批准Poherdy为Perjeta首个可互换生物类似药，420毫克规格用于HER2阳性乳腺癌
美国食品药品管理局（FDA）11月13日批准上海复宏汉霖（Shanghai Henlius Biologics）的Poherdy（pertuzumab-dpzb）作为基因泰克Perjeta（pertuzumab）的可互换生物类似药。这是Perjeta的首个获批生物类似药。
Poherdy是一种HER2/neu受体拮抗剂，规格为420毫克/14毫升（30毫克/毫升）单剂量瓶静脉注射剂，获批适应证与参照药相同，涵盖HER2阳性乳腺癌的转移性与早期治疗场景，包括与曲妥珠单抗和多西他赛联用、用于未接受过抗HER2治疗或转移性疾病化疗的HER2阳性转移性乳腺癌成人患者。
FDA表示，批准基于对广泛结构与功能产品质量属性的比较、人体药代动力学数据、临床免疫原性数据以及乳腺癌患者的支持性临床数据，证明Poherdy与Perjeta生物相似且可互换。Poherdy的处方信息包含左心室功能障碍与胚胎-胎儿毒性的黑框警告，以及输液相关反应和超敏反应/过敏性休克的警告与注意事项。复宏汉霖与Organon于2022年达成许可与供应协议，Organon拥有Poherdy在中国以外市场的独家商业化权利。
图中是美国食品药品管理局（FDA）总部入口。
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.
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：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
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