FDA approves Pfizer's Ruxience as biosimilar of Rituxan

The FDA on Tuesday announced the approval of Pfizer's Ruxience (rituximab-pvvr) as a biosimilar referencing Roche and Biogen's Rituxan (rituximab) for the treatment of adults with CD20-positive B-cell non-Hodgkin's lymphoma (NHL) to be used as a single agent or in combination with chemotherapy, as well as for adults with CD20-positive chronic lymphocytic leukaemia in combination with chemotherapy. The agency added that Ruxience is also the first biosimilar approved to treat granulomatosis with polyangiitis and microscopic polyangiitis. 

According to Pfizer, the decision was supported by a "comprehensive data package" demonstrating Ruxience's bioequivalence to Rituxan, including the Phase III REFLECTIONS B3281006 trial, which showed that the biosimilar, formerly known as PF-05280586, was equivalent to Rituxan in terms of overall response rate for the first-line treatment of patients with low tumour burden, CD20-positive follicular lymphoma. 

Pfizer noted that Ruxience is its third oncology biosimilar to gain FDA approval this year. Last month, the agency cleared Zirabev (bevacizumab-bvzr) as a biosimilar version of Roche's Avastin (bevacizumab) for the treatment of several cancer indications. In March, the FDA also cleared Trazimera (trastuzumab-qyyp), a biosimilar referencing Roche's Herceptin (trastuzumab) for breast and gastric cancer.

Meanwhile, Ruxience is the second biosimilar of Rituxan to gain US approval following Celltrion and Teva's Truxima (rituximab-abbs) last November for adults with CD20-positive B-cell NHL. Roche recorded sales of CHF 1.7 billion ($1.7 billion) for Rituxan in the first quarter.  

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