The trial showed that the proposed biosimilar matched the reference product on the basis of pharmacokinetics, efficacy, pharmacodynamics, immunogenicity, and safety in postmenopausal women having osteoporosis
Sandoz said that the integrated ROSALIA phase 1/3 clinical trial study evaluating its denosumab biosimilar candidate in comparison to the reference medicine met primary endpoints.
Denosumab is approved for the treatment of a range of conditions such as osteoporosis in postmenopausal women and in men at elevated risk of fractures. It is also approved for treatment-induced bone loss, giant cell tumour of the bone, and inhibiting skeletal related complications in cancer which have spread to the bone.
According to Sandoz, the trial showed that its proposed biosimilar matched the reference product on the basis of pharmacokinetics, efficacy, pharmacodynamics, immunogenicity, and safety in the respective indications.
The company said that this contributes to demonstration of similarity to the reference product, which is the basis for use across all indications.
Sandoz Biopharmaceuticals 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.”
The ROSALIA trial featured 527 postmenopausal women having osteoporosis. The patients were randomly grouped to get either biosimilar denosumab or the reference drug for up to 78 weeks of treatment.
Its goals were to show similar efficacy in terms of variation in lumbar spine bone mineral density along with similar pharmacokinetics and pharmacodynamics.
Denosumab, which is a human monoclonal antibody, is designed to attach to a protein called RANKL, which activates osteoclasts.
By binding to and prohibiting RANKL, denosumab lowers the production and activity of osteoclasts. This triggers a reduction of bone loss, and then the chances of fractures and other serious bone conditions, as per the summary of the product from Amgen Europe.