美国FDA批准复宏汉霖旗下两款生物类似药！中国生物药出海再添里程碑

Core Viewpoint - Henlius has received FDA approval for two biosimilar products, BILDYOS® and BILPREVDA®, which are biosimilars to PROLIA® and XGEVA®, respectively, covering all indications approved for the original products in the U.S. [1] Group 1 - The FDA approved BILDYOS® (60mg/mL) for five indications, including osteoporosis [3] - The FDA approved BILPREVDA® (120mg/1.7mL) for three indications, including bone-related events [3] - This marks Henlius's third product approved in the U.S. [3] Group 2 - The approval reflects Henlius's commitment to scientific excellence and product quality [1] - The collaboration with Organon aims to enhance the accessibility of high-quality biologics for U.S. patients [1]