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Sandoz Delivers Denosumab Data As Biogen Sues On Tysabri

Company Eyeing 2024 Denosumab Launch; Natalizumab Accepted In US, EU

 
• By Dean Rudge

Having previously identified itself as the frontrunner in the race to launch a biosimilar to Amgen’s Prolia, Sandoz has now delivered positive confirmatory data, shortly after being sued in the US over its Polpharma-partnered proposed Tysabri biosimilar.

race car
Sandoz is said to be leading the race on denosumab • Source: Shutterstock

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

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