Release of positive results for denosumab biosimilar integrated phase I/III clinical trial
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announces 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
“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. “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.”
Denosumab is indicated for treating a variety of conditions, including osteoporosis in postmenopausal women, in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that has spread to the bone, and giant cell tumor of the bone.
The results from the integrated Phase I/III study confirm the biosimilar matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in the respective indications; and contributes to demonstration of similarity, which is the basis for use in all indications.
Approximately 500 million men and women worldwide may be affected by osteoporosis1, which causes 8.9 million fractures annually – or one fracture every three seconds. By 2050, hip fractures are projected to increase by 240% in women and 310% in men compared to 1990.
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