FDA approves Celltrion, Teva's Truxima as first biosimilar of Roche's Rituxan in the US

The FDA on Wednesday announced the approval of Celltrion and Teva's Truxima (rituximab-abbs), a biosimilar of Roche's Rituxan (rituximab), for use as monotherapy or in combination with chemotherapy in adults with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL). The approval marks the first clearance of a biosimilar version of Rituxan in the US. FDA Commissioner Scott Gottlieb remarked "as part of the FDA's Biosimilars Action Plan we're advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive." 

The approval comes after an FDA advisory panel unanimously supported approval of Truxima last month. The agency had previously rejected the therapy in April after issuing a warning letter to Celltrion earlier this year for issues identified at a South Korean manufacturing facility.   

Celltrion and Teva resubmitted an application to the FDA in May seeking approval of Truxima, while the agency cleared the South Korean manufacturing plant after a repeat inspection. The drugmakers are jointly commercialising the therapy in the US and Canada under the terms of a 2016 agreement.  

Truxima was authorised in Europe last year, marking the first approval of a biosimilar monoclonal antibody for the treatment of cancer anywhere in the world.  

The FDA additionally noted Wednesday that it has approved 15 biosimilars to date, starting with Novartis' Zarxio (filgrastim-sndz), a biosimilar of Amgen's Neupogen (filgrastim), in 2015. Earlier this month, the agency approved Coherus BioSciences' Udenyca (pegfilgrastim-cbqv), as a biosimilar of Amgen's Neulasta (pegfilgrastim). 

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