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 www.gabi-journal.net 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

References
1. GaBI Online - Generics and Biosimilars Initiative. Global guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Guidelines/Global-guidelines-for-biosimilars 
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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