Sandoz’s plans to launch a denosumab biosimilar in 2024 are a step closer to materializing, after the firm posted positive results from its integrated ‘ROSALIA’ Phase I/III clinical trial comparing its GP2411 biosimilar denosumab candidate with Amgen’s Prolia original.
Results from the trial confirm that the biosimilar “matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in the respective indications; and contributes to demonstration