European Commission approves Conexxence and Bomyntra denosumab biosimilars from Fresenius Kabi for all reference indications, boosting access and the #FutureFresenius Biopharma agenda

European Commission approves Conexxence and Bomyntra denosumab biosimilars from Fresenius Kabi for all reference indications, boosting access and the #FutureFresenius Biopharma agenda

(IN BRIEF) The European Commission has approved Fresenius Kabi’s denosumab biosimilars, Conexxence® and Bomyntra®, for all uses of the originator product. These include osteoporosis treatment for postmenopausal women and at-risk men, mitigation of treatment-related bone loss, prevention of skeletal complications from bone metastases, and therapy for giant cell tumor of bone. The decision advances Fresenius Kabi’s mission to expand access to biosimilars and reinforces the firm’s Biopharma platform as part of the #FutureFresenius strategy. Both products are registered trademarks of Fresenius Kabi Deutschland GmbH.

(PRESS RELEASE) BAD HOMBURG, 23-Jul-2025 — /EuropaWire/ — Fresenius announced that the European Commission has granted marketing authorization for its denosumab biosimilars Conexxence® and Bomyntra® across Europe. The green light spans every indication of the reference medicine: treating osteoporosis in postmenopausal women and men at increased fracture risk, addressing therapy-induced bone loss, preventing skeletal-related events caused by cancer metastasizing to bone, and managing giant cell tumor of bone.

Securing these dual approvals represents a major step forward in Fresenius Kabi’s drive to broaden patient access to affordable, high-quality biosimilars. It also strengthens the company’s Biopharma platform, a cornerstone of the #FutureFresenius strategy to build sustainable growth through innovative, patient-focused therapies.

Conexxence® and Bomyntra® are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries.

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SOURCE: Fresenius Kabi AG