Regulatory challenges with biosimilars

Biosimilars/Research | Posted 08/01/2021 post-comment0 Post your comment

The World Health Organization (WHO) Expert Committee on Biological Standardization adopted guidelines for biosimilars at its 60th meeting in October 2009 [1]. Since then, according to authors from regulatory bodies across the globe, WHO ‘has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices’.


However, despite its efforts, a survey carried out by WHO in 2019‒2020 revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with non-originator products); and difficulties with the practice of interchangeability and naming of biosimilars [2].

The survey was carried out by means of a questionnaire, similar to that of a previous survey carried out by WHO in 2010. Regulatory experts in 20 countries were invited to participate in the survey and included participants from the 2010 survey, as well as experts that had been involved in WHO implementation activities during the past 10 years.

In addition to discussing the remaining challenges for biosimilars, the experts also proposed possible solutions to existing challenges identified by the survey, which included:

  1. Exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies.
  2. Use of a ‘reliance’ concept and/or joint review for the assessment and approval of biosimilars.
  3. Review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval.
  4. Setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.

The following series of four articles discuss in more detail the problems identified in the survey and possible opportunities/solutions for regulatory authorities to deal with the existing challenges.

Conflict of interest
The authors of the research paper [2] declared that there were no conflicts of interest.

Editor’s comment
Readers interested to learn more about how biosimilar guidelines differ across the world are invited to visit to view the following manuscript published in GaBI Journal:

Comparison of biosimilars guidelines

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GaBI Journal Citation Impact
1.7 – CiteScore 2019 (calculated on 6 May 2020)
2.0 – CiteScoreTracker 2020 (Last updated on 7 December 2020)

Related articles
Interchangeability, naming and pharmacovigilance of biosimilars

Regulatory issues related to quality of biosimilars

Biosimilars and lack of resources

Biosimilars and availability of reference products

Guidelines for biosimilars around the world


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. GaBI Online - Generics and Biosimilars Initiative. Global guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: 
2. 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.

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