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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

Executive Summary

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.

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