Biosimilar competition to Xolair, one of the largest monoclonal antibodies coming off patent in the middle of this decade, has been pushed back to an unknown date in the US, as Celltrion awaits news from the US FDA on its biosimilar application.
In a volte-face, Roche has outlined that it anticipates no US biosimilars to its Xolair (omalizumab) asthma and chronic hives blockbuster in 2025 – despite key omalizumab formulation patents expiring in November next year.
The Swiss originator was challenged several times on its forecast, after announcing it in prepared remarks during the firm’s third-quarter earnings call.
ANI Pharmaceuticals says it has delivered an “exceptionally strong first quarter,” with total sales reaching over $197m, amid plans to kick off a Phase IV clinical trial for Cortrophin Gel for acute gouty arthritis later this year.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.
Aurobindo’s run of biosimilar registration successes continues, with the firm’s CuraTeQ subsidiary picking up approval for its Zefylti version of filgrastim in the UK.
