Sandoz Delivers Denosumab Data As Biogen Sues On Tysabri
Company Eyeing 2024 Denosumab Launch; Natalizumab Accepted In US, EU
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.
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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.
February brings a potentially sizeable launch in the US, multiple court cases in both the US and Europe and a gala generics and biosimilars event stretching across four days in Florida.
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.