Sandoz proposed biosimilar rituximab accepted for review by the FDA

September 12, 2017 11:38 AM

Sandoz, a Novartis Division, announced today 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).

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 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. “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.”

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). Sandoz believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality.

Sandoz has five biosimilars marketed worldwide, as well as a global pipeline and plans to launch a total of five major oncology and immunology biosimilars between 2017 and 2020. This includes biosimilar rituximab, which was approved by the European Commission for use in Europe in June 2017 (marketed as Rixathon).

 

Source: Sandoz press release

 

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