Novartis subsidiary Sandoz has reported positive data from the integrated Phase I/III ROSALIA clinical trial of its proposed biosimilar denosumab to treat osteoporosis.
The trial enrolled 527 postmenopausal women with osteoporosis.
These subjects were randomised to take either biosimilar denosumab or the reference product for up to 78 weeks.
Demonstrating the similarity in efficacy as per the variation in lumbar spine bone mineral density and pharmacokinetics and pharmacodynamics were the objectives of the trial.
The latest trial findings are anticipated to back approval from various regulatory bodies for the biosimilar.
Meeting primary endpoints, the trial showed that the biosimilar had pharmacodynamics, pharmacokinetics, safety, efficacy, and immunogenicity in line with the reference medicine for the respective indications.
Demonstrating similarity is the base for usage of the biosimilar in all indications in which the reference medicine is used.
A human monoclonal antibody, denosumab attaches to the RANKL protein, which activates cells called osteoclasts linked to bone tissue disintegration.
By attaching to and hindering RANKL, denosumab lowers osteoclast production and activity, resulting in bone loss reduction. This further reduces the chances of fractures and other serious bone ailments.
Apart from osteoporosis in postmenopausal women, treatment with denosumab is indicated for various ailments including for men at high fracture risk, and bone loss caused by other treatment, among others.
Sandoz Biopharmaceuticals Development global head Florian Bieber said: “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.”
In July this year, the European Medicines Agency and the US Food and Drug Administration agreed to review applications for a proposed biosimilar natalizumab to treat multiple sclerosis.