Organon & Co. Secures FDA Approval for BILDYOS and BILPREVDA, Expanding Access to Critical Bone Care Treatments in the U.S

Reuters

09/02

Organon & Co. Secures FDA Approval for BILDYOS and BILPREVDA, Expanding Access to Critical Bone Care Treatments in the U.S

Organon & Co. has announced the FDA approvals of two new biosimilars, BILDYOS and BILPREVDA, marking a significant advancement in expanding access to critical bone care treatments in the United States. These approvals are a result of a collaboration with Henlius, which granted Organon exclusive commercialization rights to these biosimilars, excluding China. This milestone underscores Organon's commitment to improving access and affordability of treatments, particularly for conditions like osteoporosis that affect a large segment of the aging population, especially women. The biosimilars were approved based on comprehensive data demonstrating their similarity and effectiveness compared to their reference products, PROLIA and XGEVA.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Organon & Co. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250902605751) on September 02, 2025, and is solely responsible for the information contained therein.

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