The results of a survey carried out by the World Health Organization (WHO) in 2019‒2020  revealed that, despite the efforts of the organization in helping Member States implement the evaluation principles in the WHO biosimilar guidelines  into their regulatory practices, challenges still remain. Lack of resources was one of the challenges identified from the results of the survey.
Lack of resources
WHO recognizes that insufficient resources for national regulatory authorities are a common problem and this is likely to continue. This, they also recognize, may mean that in some countries implementation of the WHO guidelines is likely to be slow or may not even occur.
Problems related to lack of resources identified by the survey included lack of expertise and limited regulatory resources. It was proposed by the regulatory experts that the challenge of lack of expertise ‘may be reduced by relying on information available from other regulatory authorities that have assessed particular products and also by joint review of applications’. This could also solve the problem of limited regulatory resources by ‘offering an opportunity for an efficient and effective regulatory process for biosimilar evaluation’.
Avoiding repetition was another solution proposed to alleviate the problem of limited regulatory resources. Countries should therefore ‘avoid repeating assessments/evaluations for products that have already undergone rigorous evaluation in other countries’.
Finally, the experts also recommended that WHO prequalification project should be a guide for low‐ and middle‐income countries that lack regulatory resources for the assessment and procurement of biosimilars. This, according to the experts, ‘would also explore more possibility for regulatory convergence at the global level and contribute to increasing access to quality‐assured biotherapeutic products, including biosimilars’.
The WHO Prequalification of Medicines Programme ensures that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy . The WHO Biosimilar Guidelines are considered as a WHO‐written standard and used as a basis for the WHO prequalification for biosimilars. WHO launched a pilot project to prequalify selected biosimilars in October 2017 . The organization prequalified its first biosimilar, trastuzumab, in December 2019  and rituximab in May 2020 .
In November 2019, WHO also launched a prequalification programme for biosimilar insulin .
Conflict of interest
The authors of the research paper  declared that there was no conflict of interest.
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Regulatory challenges with biosimilars
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1. Kang HN, Thorpe R, Knezevic I, et al. Regulatory challenges with biosimilars: an update from 20 countries. Ann N Y Acad Sci. 2020 Nov 21. doi: 10.1111/nyas.14522. Epub ahead of print.
2. GaBI Online - Generics and Biosimilars Initiative. Global guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Guidelines/Global-guidelines-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. WHO prequalification programme for medicines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Policies-Legislation/WHO-prequalification-programme-for-medicines
4. GaBI Online - Generics and Biosimilars Initiative. WHO launches consultation on prequalification of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-consultation-on-prequalification-of-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. WHO prequalifies first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/WHO-prequalifies-first-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. WHO prequalifies first rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/WHO-prequalifies-first-rituximab-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. WHO launches insulin prequalification programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-insulin-prequalification-programme
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Regulatory issues related to quality of biosimilars
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