FDA approves denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) – Fresenius Kabi

Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the FDA. These denosumab biosimilars are approved for all indications of the reference products: Prolia (denosumab) and Xgeva (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars.

“We are pleased to have reached a global settlement with Amgen for our denosumab biosimilar candidates and to continue to provide patients around the globe with access to high-quality biological medicines. This marks our sixth FDA biosimilar approval, expanding our portfolio to provide more affordable therapies to patients in the US,” said Dr. Sang Jin Pak, President Fresenius Kabi Biopharma.

The FDA approval is based on comprehensive analytical development and similarity assessment supported by two comparative clinical studies: a pharmacokinetic, pharmacodynamic, and immunogenicity study in healthy volunteers, and an efficacy, pharmacodynamic, safety, and immunogenicity study in women with postmenopausal osteoporosis.

The key patents protecting Amgen’s Prolia and Xgeva (both containing the active ingredient denosumab) expired in the US on February 19, 2025, paving the way for biosimilar versions.