Sandoz files MAA at EU for rituximab biosimilar for same indications as the reference product.
Sandoz, a Novartis division and the global leader in biosimilars, announced that the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche's EU-licensed MabThera (rituximab). Rituximab is a monoclonal antibody that is used to treat non-Hodgkin's lymphoma, which includes follicular lymphoma and diffuse large B-cell lymphoma, chronic lymphocytic leukemia and autoimmune diseases such as rheumatoid arthritis. Sandoz is seeking approval for the same indications as the reference product.
Comment: Rituximab patent expiry is 22 September 2016 in the US and in the EU the patents expired on 12 November 2013.
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