FDA to Review BLA for Sandoz Rituximab Biosimilar

The Center for Biosimilars Staff
September 12, 2017
Sandoz announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed rituximab biosimilar. The drug is referenced on Rituxan, which is approved to treat blood cancers and immunological diseases.

The BLA’s data package includes analytical, preclinical, and clinical data, including a pharmacokinetic and pharmacokinetic trial of the proposed drug in the ASSIST-RA rheumatoid arthritis trial phase 3 confirmatory safety and efficacy data from the ASSIST-FL follicular lymphoma study.

Sandoz says that it hopes its drug will, if approved, help reduce the high cost of biologic treatment. “The cost of treating cancer in the [United States] 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 biopharmaceuticals development for Sandoz. “With the FDA acceptance of our regulatory submission for proposed biosimilar rituximab, we plan to…[free] up resources for and [support] patient access in other areas of cancer care including innovative therapies.”

In June, Sandoz received approval from the European Commission to market its rituximab biosimilar in Europe. Under the name Rixathon, Sandoz’s product is approved to treat all indications of the reference rituximab. Sandoz called the product 1 of 5 major launches the company has planned for the coming 4 years.

While the reference rituximab already faces competition from biosimilars in Europe, the global market for the drug has continued to grow; the branded drug earned $8.58 billion for Genentech in 2016, an increase of 2.7% from its 2015 sales.


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