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WHO prequalifies first rituximab biosimilar Posted 05/06/2020

The World Health Organization (WHO) has prequalified its first rituximab biosimilar as part of its efforts to make life-saving treatments more affordable and available to patients globally.

WHO prequalification of medicines is a service provided by the organization to assess the quality, safety and efficacy of medicinal products. It was started in 2002 in partnership with UNAIDS (Joint United Nations Programme on HIV/AIDS), UNICEF (United Nations Children's Fund) and the UN Population Fund, with support from the World Bank [1]. At the end of 2019, the WHO List of Prequalified Medicinal Products contained 558 medicines.

WHO launched a consultation on its pilot project for prequalifying biosimilars in October 2017 [1] and launched the prequalification project for rituximab and trastuzumab in July 2018 [2]. In April 2019, the agency reported positive results from the pilot project and reported that 18 dossiers for rituximab and trastuzumab had been received [3].

WHO announced on 25 May 2020 the prequalification of Celltrion’s rituximab biosimilar (CT‑P10) at doses of 100 mg and 500 mg. This rituximab biosimilar, which is used to treat non-Hodgkin’s lymphoma and leukaemia, is the second biosimilar to be WHO prequalified. Samsung Bioepis also had its trastuzumab biosimilar, which is a treatment for breast cancer, prequalified by WHO in December 2019 [2].

In November 2019, WHO launched a prequalification programme for biosimilar insulin [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. WHO launches consultation on prequalification of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-consultation-on-prequalification-of-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. WHO prequalifies first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from: www.gabionline.net/Biosimilars/General/WHO-prequalifies-first-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. WHO prequalification for rituximab and trastuzumab: first results [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from: www.gabionline.net/Reports/WHO-prequalification-for-rituximab-and-trastuzumab-first-results
4. GaBI Online - Generics and Biosimilars Initiative. WHO launches insulin prequalification programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-insulin-prequalification-programme

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Source: WHO

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