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Sandoz Maintains Lead On Denosumab As It Files With FDA

Firm ‘Among The First’ To Submit US Application For Prolia/Xgeva Biosimilar

 
• By Dave Wallace

Sandoz has confirmed that its denosumab biosimilar BLA has been accepted for review by the US FDA. The company – which has previously characterized its development program as a frontrunner compared to other proposed Prolia/Xgeva rivals – indicated that it was “among the first” to file.

Sign outside of FDA's headquarters in White Oak, MD
Sandoz’s BLA for denosumab has been accepted by the FDA • Source: Alamy

Sandoz has seen its application for a biosimilar version of Prolia/Xgeva (denosumab) accepted for review by the US Food and Drug Administration, maintaining what it has previously characterized as a leading position compared to other denosumab developers.

The Novartis subsidiary has for years characterized its GP2411 development program as an industry frontrunner, in late 2020 describing it...

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