Research & Development
Sandoz submits BLA with US FDA for proposed biosimilar for Rituxan (rituximab) to treat blood cancers
12 September 2017 -

Biosimilar company Sandoz said on Monday that it has successfully filed its Biologics License Application (BLA) with the US Food and Drug Administration (FDA) under the 351 (k) pathway for the proposed biosimilar for the reference medicine Rituxan (rituximab) for the treatment of blood cancers and immunological diseases.

According to the company, Rituxan is used to treat blood cancers including non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis.

The company added that the BLA consists of a comprehensive data package that includes analytical, preclinical and clinical data. Clinical studies included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-RA) and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL). The data confirms that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality.

In conjunction, the company has five biosimilars approved worldwide, including biosimilar rituximab, which was approved in Europe in June 2017. It plans to launch a five major oncology and immunology biosimilars between 2017 and 2020, including biosimilar rituximab, which was approved in Europe in June 2017 as Rixathon.