Celltrion’s Rituximab Biosimilar Is The First Greenlit By The FDA
Truxima (rituximab-abbs) becomes the first biosimilar to Rituxan approved by the US agency, although launch timing remains unclear; Celltrion also has novel infliximab subcutaneous formulation accepted for review by the EMA.
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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.
Teva and Celltrion have launched the first biosimilar rituximab in the US, introducing Truxima at a 10% discount to Roche’s Rituxan.
By mid-February next year, Pfizer plans to have introduced in the US bevacizumab, rituximab and trastuzumab biosimilars to Avastin, Rituxan and Herceptin.