Sandoz' biosimilar of denosumab Phase I/III clinical trial

Sandoz, the generic and biosimilar medicines unit of Novartis (NOVN: VX), which the Swiss pharma giant last month said it would hive off into a n ew publicly traded company, today announced further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab.

Marketed under the trade name Prolia, denosumab is an antiresorptive treatment for osteoporosis originated by US biotech major Amgen (Nasdaq: AMGN), which recorded sales of $922 million for the drug in second-quarter 2022.

“Biosimilars have the opportunity to create a substantial positive impact on patient access and healthcare systems sustainability,” said Florian Bieber, global head of development, Sandoz Biopharmaceuticals, adding: “Therefore, this important milestone means that we are one step closer to giving individuals living with osteoporosis access to a more affordable, biosimilar version of this critical medicine, which may help to change the course of their disease.”