Regulatory Affairs

FDA rejects Sandoz’s BLA for proposed biosimilar rituximab

PBR Staff Writer Published 03 May 2018

The US Food and Drug Administration (FDA) has rejected Sandoz’s biologics licensing application (BLA) for its proposed biosimilar rituximab.

Novartis firm Sandoz received a complete response letter (CRL) regarding the BLA for biosimilar rituximab and is planning to conduct further discussions with FDA to bring the medicine to the US patients.

In September 2017, the FDA accepted Sandoz’s BLA for review of biosimilar rituximab, which is used to treat blood cancers such as non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis.

Sandoz submitted the BLA based on clinical studies, including pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis and phase III confirmatory safety and efficacy study in follicular lymphoma.

In June 2017, Sandoz received approval from the European Commission (EC) for its Rixathon (biosimilar rituximab) to treat blood cancers and immunological diseases.

The approval was granted for Rixathon to be used in all indications of the reference medicine, MabThera.

Sandoz secured approval for Rixathon to treat non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, in addition to immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The approval was based on a development program, including analytical, preclinical and clinical data, showing biosimilarity of Rixathon to the reference medicine MabThera.

Sandoz is engaged in the development of biosimilar medicines, and is currently marketing five biosimilar medicines in different countries across the world.

In April this year, Sandoz and Pear Therapeutics have agreed to jointly commercialize and continue development of novel prescription digital therapeutics designed to treat disease and improve clinical outcomes for patients.

The partnership will use Sandoz expertise in launching and commercializing treatments, and Pear's experience in digital therapeutics design and implementation.

The collaboration is part of Sandoz and Novartis strategic effort to work with innovative digital health care providers to advance medical innovation.