- 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
Sandoz, a global leader in out- patent( general and biosimilar) drugs, moment announces farther progress on its biosimilar channel, with the release of positive results from the integrated ROSALIA Phase I/ III clinical trial study for its proposed biosimilar denosumab.
“ Biosimilars have the occasion to produce a substantial positive impact on patient access and healthcare systems sustainability, ” said Florian Bieber, Global Head of Development, Sandoz Biopharmaceuticals. “ thus, this important corner means that we’re one step closer to giving individualities living with osteoporosis access to a more affordable, biosimilar interpretation of this critical drug, which may help to change the course of their complaint. ”
Denosumab is indicated for treating a variety of conditions, including osteoporosis in postmenopausal women, in men at increased threat of fractures, treatment- convinced bone loss, forestallment of cadaverous affiliated complications in cancer that has spread to the bone, and giant cell excrescence of the bone.
The results from the integrated Phase I/ III study confirm the biosimilar matches the reference drug in terms of pharmacokinetics, pharmacodynamics, efficacity, safety and immunogenicity in the separate suggestions; and contributes to demonstration of similarity, which is the base for use in all suggestions.
Roughly 500 million men and women worldwide may be affected by osteoporosis1, which causes8.9 million fractures annually – or one fracture every three seconds1. By 2050, hipsterism fractures are projected to increase by 240 in women and 310 in men compared to 19901.
The results come soon after Sandoz verified acceptance of license operations for two other proposed biosimilars. In July 2022, the operation 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 operations for the high- attention expression 100 mg/ mL( HCF) of its biosimilar adalimumab.
Sandoz biosimilars help cases, in areas including immunology, oncology, nephrology, probative care and endocrinology, access critical and potentially life- changing drugs sustainably and affordably. Sandoz has a leading global portfolio with eight retailed biosimilars and a farther 15- plus in colorful stages of development.
In ROSALIA, 527 postmenopausal women with osteoporosis were randomized to admit either biosimilar denosumab or the reference drug for over to 78 weeks of treatment. objects were to demonstrate analogous efficacity in terms of change in lumbar chine bone mineral viscosity, as well as analogous pharmacokinetics and pharmacodynamics. The global clinical program for biosimilar denosumab was developed in discussion with major nonsupervisory agencies and the results from this clinical study are anticipated to support nonsupervisory blessing.
Denosumab is a mortal monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts( cells involved in breaking down bone towel) 2. By binding to and inhibiting RANKL, denosumab decreases the product and exertion of osteoclasts, performing in a reduction of bone loss, and latterly the liability of fractures and other serious bone conditions2.
Sandoz, a Novartis division, is a global leader in general medicinals and biosimilars. Our purpose is to innovate access for cases by developing and commercializing new, affordable approaches that address unmet medical requirements. Our ambition is to be the world’s leading and utmost valued generics company. Our broad portfolio of high- quality drugs, covering all major remedial areas, reckoned for 2021 deals of USD9.6 billion.