FDA Accepts Proposed Biosimilar to Rituximab for Review


Rituxan is used to treat blood cancers and immunological diseases.

Today, the FDA accepted the Biologics Licensing Application (BLA) for a proposed biosimilar to rituximab (Rituxan).

Rituximab is indicated to treat immunological diseases such as rheumatoid arthritis (RA), as well as blood cancers.

Included in the BLA is a comprehensive data package of analytical, preclinical, and clinical data, according to a press release. Clinical data included a pharmacokinetic and pharmacodynamic trial in patients with RA, and a phase 3 confirmatory safety and efficacy study in patients with follicular lymphoma.

“The cost of treating cancer in the US is a major concern for many patients and their families as well as for the health care system,” Mark Levick, MD, PhD, Global Head of Development, Biopharmaceuticals at Sandoz, said in the release. “With the FDA acceptance of our regulator submission for proposed biosimilar rituximab, we plan to deliver patients a high-quality Sandoz biosimilar that, following approval, could help drive health care savings and increase competition, while freeing up resources for and supporting patient aces in other areas of cancer care including innovative therapies.”

Sandoz believes the data further confirms that the biosimilar rituximab matches the reference product rituximab in safety, efficacy, and quality.

The manufacturer plans to launch a total of 5 major oncology and immunology biosimilars between 2017 and 2020, according to the release. This included the biosimilar rituximab—–marketed as Rixathon––which was approved by the European Commission in June 2017.

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