FDA Issues CRL to Sandoz for Rituximab Biosimilar

The BLA was originally accepted by the FDA for review in September 2017, with the product intended to be used for the treatment of immunological conditions such as rheumatoid arthritis, as well as blood cancers.

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Sandoz for its submission of a Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.

The BLA was originally accepted by the FDA for review in September 2017, with the product intended to be used for the treatment of immunological conditions such as rheumatoid arthritis, as well as blood cancers.

“Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible,” the company declared in a statement.

The submission included data from analytical, preclinical, and clinical phases of the study process, including the ASSIST-RA trial in rheumatoid arthritis, the findings of which were published in the Annals of Rheumatic Diseases and revealed that the product demonstrated bioequivalence to the originator therapy. Ultimately, the primary objective was met, with the ratio of the geometric means being 1.064, and the 90% confidence interval maintained within the standard bioequivalence limits (0.8 to 1.25). No clinically meaningful differences were found between the Sandoz product and the originator.

In June 2017, the biosimilar was accepted by the European Commission for use in Europe and was marketed as Rixathon.

Mark Levick, MD, PhD, the Global Head of Development of Biopharmaceuticals, said in a statement at the time of the BLA acceptance that “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.”

Sandoz stated that it is committed to increasing access to biosimilars for life-enhancement, and currently has 5 additional biosimilars marketed worldwide.