EMA Accepts Sandoz’s Regulatory Filing for Biosimilar Rituximab

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Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

Sandoz, a Novartis division, announced that EMA has accepted their regulatory submission for its biosimilar version of Roche’s EU-licensed monoclonal antibody MabThera (rituximab), used in the treatment of 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. This submission marks the sixth of 10 regulatory filings that the company plans to submit between 2015 to 2017.

According to Sandoz, the company has included, in the regulatory submission, data to demonstrate that its biosimilar version has essentially the same biological substance as, and the final drug product is highly similar to, the reference product. In addition to analytical, functional, and preclinical data, the submission includes data from two pivotal confirmatory safety, pharmacokinetic/pharmacodynamics, and efficacy studies that involved 629 follicular lymphoma and 173 rheumatoid arthritis patients.

The company’s CEO and division head, Richard Francis, said in a press statement that the approval of the rituximab biosimilar will help broaden patient access to this therapy and allow healthcare resources to be used for funding other innovative medicines.


The biosimilar version of rituximab is part of the Sandoz’s expanding 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.

Source: Novartis