FDA accepts Novartis' filing seeking approval of Rituxan biosimilar

Novartis' Sandoz unit announced Tuesday that the FDA accepted a filing under the 351 (k) pathway for its proposed biosimilar version of Biogen and Roche's Rituxan (rituximab). Sandoz's biosimilar version of the product was approved in Europe in June, where it is marketed as Rixathon.

"The cost of treating cancer in the US is a major concern for many patients and their families as well as for the healthcare system," remarked Mark Levick, global head of development, biopharmaceuticals at Sandoz. Rituxan is used to treat blood cancers including non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, as well as immunological diseases such as rheumatoid arthritis.

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According to Sandoz, the submission to the FDA includes analytical, preclinical and clinical data, including a pharmacokinetic/pharmacodynamic trial in rheumatoid arthritis and a Phase III study in follicular lymphoma. The company said it "believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality."

For related analysis, read Physician Views Poll Results: The 'Novartis' factor will increase comfort levels with Rixathon, but Roche holds some key cards in biosimilar showdown.

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