Regulatory issues related to quality of biosimilars

Biosimilars/Research | Posted 05/02/2021 post-comment0 Post your comment

The quality of biosimilars was one of the challenges identified from the results of a survey carried out by the World Health Organization (WHO) [1]. The survey, which was carried out in 2019‒2020, revealed that despite the efforts of WHO in helping Member States implement the evaluation principles in the WHO biosimilar guidelines [2] into their regulatory practices, challenges still remain.


Quality of biosimilars
The WHO survey found that there was a significant problem with the quality of some biosimilars (and even more with non-originator products). They noted that ‘some countries have products called biosimilars but that were approved prior to the establishment of a regulatory framework for biosimilars approval’. WHO has recommended avoiding use of the term similar biotherapeutic product (SBP) or biosimilar for products that have not been evaluated in line with the principles in the WHO Biosimilar Guidelines.

The WHO Expert Committee on Biological Standardization adopted guidelines for biosimilars at its 60th meeting in October 2009 [2]. The guidelines contain advice on such problems/products, which WHO believes should help to alleviate this problem, however, it also recognizes that this will clearly take time and requires resources.

The authors acknowledge that the problem of being able to clearly distinguish between real biosimilars and non-biosimilar, non-originator products continues and is compounded by products being called biosimilars when they are not. They add that ‘the terminology used for [non-originator] products should not be confused by calling them biosimilars, and such products may need to be reassessed by regulatory authorities to establish their suitability for clinical use/marketing’. This calls for an efficient and comprehensive pharmacovigilance system and will also require post-marketing surveillance. This, according to the experts, is the only way to ensure the efficacy and safety of biologicals, including biosimilars.

Pharmacovigilance is especially important as some clinical issues only become evident during such pharmacovigilance phases due to the low incidence of their occurrence. This has been highlighted by examples such as the unwanted immunogenicity issues with erythropoietin products that leads to pure red cell aplasia (PRCA) [3]. Although erythropoietin induced PRCA is a very serious problem, its incidence is relatively low, making it normally undetectable during clinical trials. It can, however, be detected during the pharmacovigilance stages.

Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.

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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. ang 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 []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: 
3. GaBI Online - Generics and Biosimilars Initiative. Epoetin alfa and pure red cell aplasia []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from:

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