Sandoz’s Denosumab Meets Primary Endpoints in Phase 3 Trial

The biosimilar matches Prolia in efficacy, immunogenicity, pharmacodynamics, and pharmacokinetics in women who are postmenopausal with osteoporosis.

Sandoz, a company associated with Novartis, announced the release of positive results from the integrated ROSALIA phase 1/3 clinical trial (NCT03974100) study about denosumab which is the biosimilar for Prolia from Amgen.

Denosumab is a human monoclonal antibody that binds to the RANKL protein, which is an activator of osteoclasts. This decreases the production and activity of osteoclasts, resulting in a reduction of bone loss and the likelihood of fractures and other serious bone conditions.

“Biosimilars have the opportunity to create a substantial positive impact on patient access and health care systems sustainability,” Florian Bieber, global head of Development at Sandoz Biopharmaceuticals, said in a statement. “Therefore, this important milestone means that we are 1 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 to treat a variety of conditions, including osteoporosis in postmenopausal women, in men at an increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that has spread to the bone, and giant cell tumors on the bone.

The study results showed that the biosimilar matches the reference medication in efficacy, immunogenicity, pharmacodynamics, pharmacokinetics, and safety. It also showed that the drug contributed to the demonstration of similarity, which is the basis for use in all indications.

The ROSALIA study included 527 women who are postmenopausal with osteoporosis who were randomized to receive either the biosimilar denosumab or the reference medication for up to 78 weeks of treatment.

Investigators wanted to demonstrate the similar efficacy in terms of change in lumbar spine bone mineral density, pharmacokinetics, and pharmacodynamics. The clinical program was developed in consultation with major regulatory agencies.

The results came after Sandoz confirmed the acceptance of the license applications for 2 other proposed biosimilars from the company.

In July 2022, the European Medicines Agency and the FDA accepted for review the application for the proposed biosimilar natalizumab for multiple sclerosis. Additionally, in June 2022, the agencies accepted Sandoz’s applications for the high-concentration formulation 100 mg/mL of its biosimilar adalimumab for review.

Sandoz has 8 marketed biosimilars with a further 15-plus in various stages of development.

Reference

Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated phase 1/3 clinical trial. News release. Novartis. September 19, 2022. Accessed September 20, 2022. https://www.novartis.com/news/media-releases/sandoz-announces-further-progress-its-biosimilar-pipeline-release-positive-results-denosumab-integrated-phase-iiii-clinical-trial