Core Viewpoint - The European Commission has approved the marketing authorization for two biosimilars of denosumab, BILDYOS® and BILPREVDA®, developed by Fuhong Hanlin in collaboration with Organon, covering all indications of the original products in the EU [1] Group 1: Company Developments - Fuhong Hanlin's Chief Business Development Officer, Cao Ping, emphasized that this approval represents a significant achievement in meeting the needs of European patients and healthcare systems [1] - The approval of BILDYOS and BILPREVDA is based on a comprehensive review of data, including structural and functional analysis, clinical pharmacokinetics, and a clinical comparative study [1] Group 2: Product Characteristics - The clinical study demonstrated that BILDYOS and BILPREVDA are highly similar to the approved original product in terms of structure, biological activity, efficacy, safety, and immunogenicity characteristics [1]
美欧双批！复宏汉霖两款地舒单抗再获欧盟批准