Sandoz on Monday announced 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. 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,” said Florian Bieber, Global Head of Development, Sandoz Biopharmaceuticals in a statement.
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 a demonstration of similarity, which is the basis for use in all indications,” the company said in a statement on Monday.
Around 500 million men and women worldwide may be affected by osteoporosis, which causes 8.9 million fractures annually – or one fracture every three seconds. By 2050, hip fractures are projected to increase by 240 percent in women and 310 percent in men compared to 1990.
“The results come soon after Sandoz confirmed acceptance of license applications for two other proposed biosimilars. In July 2022, the application for the first-of-a-kind multiple sclerosis proposed biosimilar natalizumab was accepted for review by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2022, the EMA and FDA accepted for review Sandoz applications for the high-concentration formulation 100 mg/mL (HCF) of its biosimilar adalimumab,” the company added.