A survey was carried out by the World Health Organization (WHO) in 2019‒2020 covering most current topics pertinent to biosimilars [1].
The results of this survey 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. These include unavailable/insufficient reference products in the country.
Reference products
Issues related to reference products identified by the WHO survey included the following:
- Limited access to information on the reference product (comment from 13 participating countries)
- Financial constraint due to the high price of the reference product (8 countries)
- Obtaining sufficient quantities of the reference product to conduct the comparability assessment (7 countries)
- Conducting bridging studies when the reference product is sourced from outside the country (6 countries)
Possible solutions proposed by the regulatory experts were to exchange information on products between national regulatory authorities, to accept foreign‐sourced reference products and to avoid conducting unnecessary (duplicate) studies. The authors pointed to the fact that some countries have established a memorandum of understanding (MoU) to facilitate information sharing among regulatory authorities regarding the reference products.
The authors also stated that ‘unnecessary repetition of non-clinical and clinical studies already undertaken with a reference product licensed and sourced in another country needs to be avoided. For example, a version of an RBP licensed and used for biosimilarity assessment in the EU could have already had its comparability demonstrated with a version of it licensed and used in the United States.’
It was also proposed that bridging studies could be avoided ‘if existing data and information are sufficient to establish the necessary bridge’.
Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.
Editor’s comment
Readers interested to learn more about availability and use of reference products in the regulatory approval of biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Establishment of reference standards in biosimilar studies
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1.7 – CiteScore 2019 (calculated on 6 May 2020)
2.0 – CiteScoreTracker 2020 (Last updated on 10 January 2021)
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| LATIN AMERICAN FORUM – Coming soon! 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. LATIN AMERICAN FORUM – Próximamente! 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.
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References
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 15]. Available from: www.gabionline.net/Guidelines/Global-guidelines-for-biosimilars
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Biosimilars and lack of resources
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