Sandoz initiates ROSALIA study of denosumab biosimilar.

Sandoz, a Novartis division and a global leader in biosimilars, announced the first patient enrolled in ROSALIA, an integrated Phase I/III clinical study for its proposed biosimilar denosumab. The study aims to confirm that the biosimilar matches the reference medicine in terms of pharmacokinetics, efficacy, safety, and immunogenicity in patients with postmenopausal osteoporosis. The study will be conducted in osteoporosis as this is an adequately sensitive indication and representative of many patients who are treated with the medicine.

In ROSALIA, approximately 520 postmenopausal patients with osteoporosis will be randomized to receive either biosimilar denosumab or the reference medicine for 52 weeks. Following this period, patients receiving the reference medicine will be re-randomized to either continue with a third dose or transition to biosimilar denosumab, until 78 weeks of treatment. The primary endpoints include percentage change in lumbar spine bone mineral density. The global clinical program for biosimilar denosumab was developed in consultation with major regulatory agencies and the results from this clinical study are expected to support regulatory submissions.

Comment: The patents on Prolia/Xgeva will expire in the US on 19 February 2025 and will expire in Europe on 25 June 2022, except for France, Italy, Spain and the UK, expiring in 2025 .