ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis
Osteoporosis accounts for 8.9 million bone fractures annually, including debilitating hip fractures – a number set to increase substantially over next two decades1
Positive trial results follow filing acceptances for two other proposed Sandoz biosimilars, adalimumab HCF and natalizumab, by both EMA and FDA
Basel, September 19, 2022 – Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today 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 bone2,3,4,5.
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 seconds1. By 2050, hip fractures are projected to increase by 240% in women and 310% in men compared to 19901.
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.
Sandoz biosimilars help patients, in areas including immunology, oncology, nephrology, supportive care and endocrinology, access critical and potentially life-changing medicines sustainably and affordably. Sandoz has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development.
In ROSALIA, 527 postmenopausal women with osteoporosis were randomized to receive either biosimilar denosumab or the reference medicine for up to 78 weeks of treatment. Objectives were to demonstrate similar efficacy in terms of change in lumbar spine bone mineral density, as well as similar pharmacokinetics and pharmacodynamics. The global clinical program for biosimilar denosumab was developed in consultation with major regulatory agencies and the results from this clinical study are expected to support regulatory approval.
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue)2. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions2.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” etc etc.
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International Osteoporosis Foundation. Facts and Statistics. Available from: https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures [Last accessed: August 2022].
Amgen Europe B.V. Xgeva® (Denosumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf [Last accessed: August 2022].
Amgen Europe B.V. Prolia® (Denosumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/prolia [Last accessed: August 2022].
Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf [Last accessed: August 2022].
Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf [Last accessed: August 2022].
www.clinicaltrials.gov. Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients with Postmenopausal Osteoporosis. NCT03974100. Available from: https://clinicaltrials.gov/ct2/show/NCT03974100?term=GP2411&rank=1 [Last accessed: August 2022].
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