First rituximab similar biotherapeutic products prequalified


On 25 May 2020 the World Health Organization (WHO) prequalified its first rituximab biosimilar medicine in an attempt to make this expensive, life-saving treatment more affordable and available globally.

Rituximab, is a genetically engineered monoclonal antibody. The mechanism of action of rituximab is based on its targeted binding to CD20 on the surface of B-cells, and subsequent mediation of B-cell depletion and cell death. Rituximab was the first monoclonal antibody and the first B-cell-targeted therapy to be approved for therapeutic use in oncology. Rituximab has revolutionized the treatment of diffuse large B-cell lymphoma, chronic lymphocytic leukemia and follicular lymphoma, significantly improving therapeutic responses, and remains a fundamental component of treatment regimens for those cancer indications today.

However, as with all biologic medicines, the complex development and manufacturing process for rituximab have meant high treatment costs. Therefore, access to affordable versions of this effective essential medicine in nations with fewer resources and less advanced infrastructure remains limited.

WHO has invited manufacturers to submit rituximab dossiers for prequalification to facilitate access to biotherapeutic products, including similar biotherapeutic products (SBPs), at affordable prices. Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics while keeping the same quality, safety and efficacy. They are usually manufactured by other companies once the patent on the original product has expired.