Sandoz Maintains Lead On Denosumab As It Files With FDA
Firm ‘Among The First’ To Submit US Application For Prolia/Xgeva Biosimilar
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.
You may also be interested in...
Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Sandoz Expects ‘Trough Year’ In 2023 As It Counts Cost Of Spinoff
Sandoz is set for a “trough year” in 2023 as the generics and biosimilars unit faces costs linked with its spinoff from parent company Novartis that will erode its core operating income.
HK inno.N Eyes 2025 Korea Opportunity With mAbxience Denosumab Deal
Ahead of wrapping up a Phase III clinical trial for its proposed biosimilar denosumab candidate later this year, mAbxience has out-licensed marketing rights in Korea to local player HK inno.N, with a patent expiry opportunity in 2025.