On Monday, Sandoz released encouraging findings from the combined ROSALIA Phase I/III clinical trial research for its envisioned biosimilar Denosumab.

Denosumab is authorized for the treatment of a number of disorders, including giant cell tumors of the bone, men at increased risk of fractures, therapy-induced bone loss, and osteoporosis in postmenopausal women.

According to the manufacturer, the integrated Phase I/III study results show that the biosimilar is identical to the reference drug in terms of pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity for each of the relevant indications. This contributes to a demonstration of similarity, which is the foundation for use in all indications.

The results came shortly after Sandoz announced that license requests for two other potential biosimilars had been accepted. The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the application for Natalizumab, a novel multiple sclerosis suggested biosimilar, for evaluation in July 2022. The high-concentration formulation (HCF) 100 mg/mL of Sandoz′s biosimilar Adalimumab was accepted for evaluation by the EMA and FDA in June 2022. (Financial express, September 19, 2022) https://www.financialexpress.com/healthcare/pharma-healthcare/sandoz-announces-positive-results-for-its-biosimilar-denosumab/2673061/