FDA accepts license application for Novartis' rituximab biosimilar

Sandoz, Novartis’ generics and biosimilars division, has revealed that the FDA has accepted its Biologics License Application (BLA) for a proposed biosimilar version of Roche and Genentech’s Rituxan (rituximab), a treatment for blood cancers such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia, as well as rheumatoid arthritis (RA).

The firm is confident its biosimilar version will be every bit as safe and effective as its reference product, presenting a package of analytical, preclinical and clinical data as part of its BLA, drawn from studies including a Phase 3 trial in follicular lymphoma and a pharmacokinetic/pharmacodynamic trial in RA.

Sandoz’s rituximab was approved in Europe earlier this year in June. The firm already has a total of five biosimilars approved worldwide, and plans to deliver five further biosimilars in oncology and immunology between 2017 and 2020. Sandoz will have a fight on its hand in the market space, as a number of other companies race to have their own Rituxan biosimilars approved such as Cellitrion, whose own version produced promising results in June.

"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" explained Mark Levick, Global Head of Development, Biopharmaceuticals. "With the FDA acceptance of our regulatory submission for proposed biosimilar rituximab, we plan to deliver patients a high-quality Sandoz biosimilar that, following approval, could help drive healthcare savings and increase competition, while freeing up resources for and supporting patient access in other areas of cancer care including innovative therapies."