Fresenius Kabi announced July 1 that it has launched its denosumab biosimilars Conexxence and Bomyntra (denosumab-bnht), making it the second biosimilar available in this highly competitive drug category. The drug was approved by the FDA in March 2025.
The denosumab biosimilars expand Fresenius Kabi’s portfolio of marketed biosimilars to 4 drug categories (including pegfilgrastim, tocilizumab, and ustekinumab). It is awaiting an FDA decision on its rituximab biosimilar candidate.
Both products are approved for all indications of Amgen’s reference drugs Prolia and Xgeva. In its press release, Dr. San Jin Pak, President of Fresenius Kabi Biopharma, stated, “Fresenius Kabi is very pleased to continue the consistent launches of new biosimilars for US patients, providers and payors. Access to high-quality biological medicines creates the opportunity to provide more affordable therapies to patients and as our biosimilar portfolio expands, we will be able to provide access for even more patients.”
Currently, four denosumab biosimilars are approved by the FDA, but only two are launched (Sandoz’s Jubbonti/Wyost being the other), the result of patent litigation and settlements with the reference manufacturer. Celltrion had a settlement to launch in June 2025, but a marketing announcement has not been made as yet for this product or for Samsung Bioepis’ entry.
Another four biosimilar makers have sent 351(k) denosumab applications to the FDA for approval, with some decisions expected within the fourth-quarter of 2025.
(Update: On July 8, Celltrion USA announced that it launched its denosumab biosimilar products Stoboclo and Osenvelt.)
