Rituximab biosimilar prequalified by WHO

Regulatory NewsRegulatory News | 05 June 2020 |  By 

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.
A biosimilar to trastuzumab, the other biologic medication included in WHO’s pilot program, was prequalified in December 2019. Both medications are included in the agency’s Essential Medicines List.
The prequalification program run by WHO assesses the quality, safety and efficacy of medicines and other health products. Products meeting prequalification standards are then listed by WHO as eligible for procurement. “Many low-income countries also use WHO’s lists of prequalified products to guide their selection of medicines, vaccines and technologies for national procurement,” said WHO in its announcement of the trastuzumab biosimilar’s prequalification.
The average cost of treatment with the reference rituximab drug, Roche’s Rituxan, can range to the tens of thousands of dollars per year in the United States. “Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics while keeping the same quality, safety and efficacy,” said WHO, which expects the rituximab biosimilar to cost less than half the price of its originator biologic.
(RELATED: WHO to begin cancer biosimilar prequalification pilot this fall, Regulatory Focus 4 May 2017; WHO prequalifies its first biosimilar, Regulatory Focus 19 December 2019).


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Tags: Biologics, WHO

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