WHO’s revised guideline to safe and effective biosimilar products

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The review article published by Kang H-N et al. in 2023 presents the key updates that have been incorporated in the World Health Organization (WHO) revised guidelines on evaluation of biosimilars adopted by the WHO Expert Committee on Biological Standardization in April 2022 [1]. The updates include the following but are not restricted to these alone and should be read in conjunction with the guidelines [2]:

Guidance V13F21
  • The scope of revised guidelines is expanded to include well-characterized biological products rather than biotherapeutics alone with a corresponding shift to use the term 'biosimilar' rather than 'similar biotherapeutic product'. 
  • The term ‘a stepwise approach’ was deleted from the key principles for the licensing of biosimilars since it was recognized that ‘tailored’ is more appropriate to reflect the parallel development that is currently used.
  • The clarity on considerations provided for use of non-local reference products opens the door wider for global biosimilar development as some biosimilar manufacturers may want to use a reference product sourced from less-expensive markets and avoid duplicating studies already undertaken with the reference product licensed in another country.
  • Different approaches applied for clinical evaluation provide the flexibility for reducing the amount of data and the clarification on the type of data needed for regulatory approval for biosimilars.

According to the authors and following the World Health Assembly resolution on access to biotherapeutics in 2014 [3], WHO has promoted the biosimilarity paradigm for the provision of safe and effective products and provided considerable support to the WHO Member States to improve regulatory convergence.

The revised guidelines provide solutions to challenges revealed from the survey conducted in 2019 to 2020 [4-9]. They also reflect outcomes of a thorough review carried out in 2021 in view of technical developments, accumulated and emerging scientific evidence as well as experience in biosimilar evaluation in the past 10 years in order to seek an opportunity to introduce greater flexibility and to reduce regulatory requirements in biosimilar development where possible [10]. The move toward a greater emphasis on quality and functional in vitro assessment enables the reduction of cost and timelines of development and supports streamlined regulatory approval as a first critical step towards product availability resulting in more therapeutic options for patients. 

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

Abstracted by Dr Hye-Na KangWorld Health Organization, Access to Medicines and Health Products, Geneva, Switzerland.

Editor’s comment
Readers interested to learn more about biosimilars status in 16 countries are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Biosimilars – status in July 2020 in 16 countries 

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1. Kang H-N, Wadhwa M, Knezevic I. WHO guidelines on biosimilars: toward improved access to safe and effective products. Ann NY Acad Sci. 2023 Jan 24. doi:10.1111/nyas.14965
2. World Health Organization. Annex 3. Guidelines on evaluation of biosimilars. Replacement of Annex 2 of WHO Technical Report Series, No. 977 [homepage on the Internet]. [cited 2023 Feb 24]. Available from: https://cdn.who.int/media/docs/default-source/biologicals/who_trs_1043_annex-3_biosimilars_tk.pdf?sfvrsn=998a85d_1&download=true
3. World Health Organization. Access to biotherapeutic products including similar biotherapeutic products1 and ensuring their quality, safety and efficacy. 24 May 2014 [homepage on the Internet]. [cited 2023 Feb 24]. Available from:https://apps.who.int/iris/bitstream/handle/10665/162867/A67_R21-en.pdf?sequence=1&isAllowed=y
4. Kand H-N, Thorpe R, Knezevic I. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019. Biologicals. 2020;65:1-9.
5. GaBI Online - Generics and Biosimilars Initiative. Regulatory challenges with biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars and availability of reference products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars and lack of resources [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
8. GaBI Online - Generics and Biosimilars Initiative. Regulatory issues related to quality of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
9. GaBI Online - Generics and Biosimilars Initiative. Interchangeability naming and pharmacovigilance of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
10. GaBI Online - Generics and Biosimilars Initiative. WHO revised guidelines for biosimilars scientific background [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:

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