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More capacity needed in clinical trial review for national approval of biosimilars Posted 22/06/2012

The need for National Regulatory Authorities to build capacity in clinical trials review, and for WHO to continue monitoring regulatory procedures for the evaluation of biosimilars were among the main recommendations of a workshop to discuss the implementation of WHO guidelines on evaluating biosimilars in Seoul, Republic of Korea, 24–26 August 2010.

The objective of the workshop was to facilitate implementation of the newly adopted WHO Guidelines by National Regulatory Authorities (NRAs). A total of 38 experts from 13 different countries attended the workshop, which was organised jointly by WHO and the Korea Food and Drug Administration. Most were from NRAs, with others from industry and academia. Discussions focused on the current state of play in implementing the WHO Guidelines on evaluation of Similar Biotherapeutic Products (SBPs) [1].

Presentations included regional and country updates on how SBPs were being evaluated, comparability studies between SBPs and Reference Biotherapeutic Products (RBPs). A panel discussion raised concerns that the implementation of the WHO guidelines was very diverse in different countries, and that more work is needed to achieve global harmonisation on the approval and regulation of SBPs. Together with the results of a post-workshop questionnaire, the workshop produced the following conclusions and recommendations:

  • Recognition of WHO Guidelines as a tool for harmonising regulatory requirements worldwide.
  • Owing to diversity in regulatory requirements among NRAs, the WHO secretariat agreed to collect and share information on a regular basis, and to continue monitoring progress in implementation of the guidelines.
  • NRAs were recommended to publish assessment reports on their websites following the example of EMA and Health Canada.
  • The WHO Guidelines were well accepted with regard to the non-clinical evaluation of SBPs.
  • The majority of NRAs are struggling to perform review of clinical data and statistical analysis, and are encouraged to build capacity in these areas in order to standardise regulatory approval of SBPs.
  • Future workshops would need to address specific issues in more depth, including the principle of comparability to the RBPs, which some countries currently do not recognise, the issue of whether or not labels should indicate an SBP, and the quality assessment of SBPs.
  • WHO should assist NRAs in building and improving technical expertise. In this regard, participants called for a review article on the intended use of international reference preparations to be published as a tool for information sharing. This is all the more important given the challenge posed by the frequent changes of originator products.
  • WHO should revise WHO Guidelines for assuring the quality of products prepared by recombinant DNA technology (WHO TRS 814) as an opportunity to address the issue of lack of terminology for copy ‘me too’ products with only a partial comparability to an RBP.
  • To promote the sharing of information and knowledge, WHO undertook to coordinate publication of a report of the workshop in peer-reviewed literature [2], and to prepare Questions and Answers for the WHO biological website [3].

Related article

WHO guidelines on biosimilars: case studies and discussion highlights


1.  Guidelines on evaluation of Similar Biotherapeutic Products (SBPs) [monograph on Internet]. World Health Organization: WHO c2012 [cited 2012 Jun 22]. Available from:  http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf

2.  Wadhwa M, Kang H-N, Knezevic I, Thorpe R, Griffiths E. WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea, 24-26 August, 2010. Biologicals. 2011;39:349-57.

3.  Biologicals [monograph on Internet]. World Health Organization: WHO c2012 [cited 2012 Jun 22]. Available from: http://www.who.int/biologicals/en/

Source: WHO

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