Research & Development
FDA accepts BLA from Sandoz for proposed biosimilar rituximab
12 September 2017 -

Germany-based developer of generic pharmaceuticals and biosimilars Sandoz said on Tuesday that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine Rituxan (rituximab).

Sandoz is a division of Swiss major multinational Novartis (VTX: NOVN).

Rituxan is indicated to treat blood cancers, such as non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia. It is also used in the treatment of immunological diseases like rheumatoid arthritis.

"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," said Mark Levick, MD PhD, global head of development, Biopharmaceuticals, at Sandoz.

"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."