International – Rituximab biosimilar prequalified by WHO

The World Health Organization (WHO) has prequalified South Korean drugmaker Celltrion’s biosimilar version of rituximab, the second product achieving that status under a biosimilar prequalification pilot begun by the agency in 2018.
“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,” noted WHO in its announcement of the prequalification. Rituximab is also used to treat rheumatoid arthritis as well as granulomatosis with polyangiitis.

The prequalification pilot program for rituximab and another monoclonal antibody, trastuzumab, is meant to smooth the path to greater adoption of these effective therapies in nations with fewer resources.