Sandoz receives FDA approval for first and only denosumab biosimilar

Sandoz (SIX: SDZ), the recent generic and biosimilar medicines spin out from Novartis (NOVN: VX), has announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines.

The biosimilars reference US biotech major Amgen’s (Nasdaq: AMGN) Xgeva and Prolia, which generated $2.1 billion and $4 billion, respectively, in full-year 2024.

Keren Haruvi, president Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."