Sandoz’s biosimilar version of MabThera accepted for EU regulatory review

Sandoz has announced that its new biosimilar version of the monoclonal antibody rituximab has been accepted for European regulatory review.

The European Medicines Agency has accepted the marketing authorisation application for the biosimilar version of rituximab, the original branded version of which was created by Roche and is sold under the name MabThera.

It is used to treat non-Hodgkin's lymphoma, including follicular lymphoma and diffuse large B-cell lymphoma, as well as chronic lymphocytic leukaemia and autoimmune diseases such as rheumatoid arthritis.

Sandoz is seeking approval for the same indications as the reference product, with multiple clinical trials involving more than 800 patients showing the biosimilar provides the same level of performance.

This marks the sixth of ten regulatory filings planned by Sandoz between 2015 and 2017.

Richard Francis, division head and chief executive officer of Sandoz, said: "If approved, we believe our biosimilar rituximab will help broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines."