EMA Accepts Sandoz’s MAA for a Biosimilar of Roche’s MabTheraBy
Sandoz, a Novartis division, reports that the European Medicines Agency has accepted the marketing authorization application for a biosimilar to Roche’s European Union (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.
Sandoz currently markets three biosimilars. Biosimilar rituximab is part of Sandoz’ growing oncology and immunology portfolios. The oncology portfolio includes two marketed products (filgrastim and epoetin-alfa) and biosimilar candidate pegfilgrastim, which is under regulatory review in the US and EU. This is the tenth regulatory filing that the company plans to submit over a three-year period (2015-2017).