FDA Approves Pfizer's Ruxience Rituximab Biosimilar
Pfizer has received approval from the US Food and Drug Administration for the country’s second biosimilar rituximab, under the Ruxience label. However, the company has not yet revealed launch plans for the rival to Roche’s Rituxan brand.
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Amgen’s FDA submission for a biosimilar of Roche’s Rituxan rituximab brand comes shortly after Teva launched the first direct rival to the oncology drug in the US.
Truxima will launch in the US on 11 November for oncology indications at a 10% discount to the list price of Roche’s innovator Rituxan. The launch marks Teva's first biosimilar launch in the US.
Teva and Celltrion have launched the first biosimilar rituximab in the US, introducing Truxima at a 10% discount to Roche’s Rituxan.