Novartis: Positive results for denosumab trial

( – Sandoz announces further progress in its biosimilar portfolio, with the publication of positive results for the integrated Phase I/III clinical trial of denosumab.

The ROSALIA study met the primary endpoints, confirming that the proposed biosimilar denosumab matches the reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis.

Positive trial results follow EMA and FDA filing acceptance of two other proposed Sandoz biosimilars, adalimumab HCF and natalizumab

Osteoporosis is responsible for 8.9 million bone fractures a year, including debilitating hip fractures – a number that is expected to rise dramatically over the next two decades.

“Biosimilars have the potential to create a substantial positive impact on patient access and the sustainability of healthcare systems,” said Florian Bieber, Global Head of Development, Sandoz Biopharmaceuticals. ‘So this milestone means we are one step closer to giving people with osteoporosis access to a more affordable biosimilar version of this essential medicine, which could help modify the course of their disease.’

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