复宏汉霖帕妥珠单抗生物类似药POHERDY获美国FDA批准

Core Insights - The biopharmaceutical license application (BLA) for Pertuzumab injection (420mg/14mL) POHERDY has been approved by the U.S. Food and Drug Administration (FDA), making it the first and only biosimilar to PERJETA (pertuzumab) in the U.S. market [1][1][1] - This approval allows for interchangeability with the original product PERJETA and covers all indications for which PERJETA has been approved in the U.S. [1][1][1] - The approval represents a significant milestone in improving access to high-quality and potentially more affordable treatment options for patients with specific HER2-positive breast cancer [1][1][1]