WHO asks for comments on new biosimilar Q&A

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As part of plans to provide additional clarification of its 2009 guidelines on the evaluation of biosimilars, the World Health Organization (WHO) has drafted a new document providing answers to questions that regulators have posed over the past eight years.

Review committee V15a16

The draft question-and-answer (Q&A) document addresses the following subjects:

  • scientific considerations and concept for licensing similar biotherapeutic products (SBPs)
  • key principles for licensing SBPs
  • reference biotherapeutic products
  • quality
  • non-clinical evaluation
  • clinical evaluation
  • pharmacovigilance
  • prescribing information and label
  • roles and responsibilities of national regulatory authorities

The document addresses basic questions, such as the meaning of the terms SBP and reference biotherapeutic product, as well as more complex issues, such as how to handle differences in immunogenicity and the duration of clinical studies. Other topics covered in the Q&A include how many batches of a product should be tested in comparability studies, how comprehensive an evaluation of glycan structure should be, and how updates to safety information for a reference product should be handled for approved biosimilars, among others.

Biosimilar products have been licensed in some countries as generics or as small molecule drugs with supporting data that do not meet WHO’s regulations, the agency stated.

The contents of the draft document, which WHO emphasizes must be read in the context of the guidelines, were selected on the basis of the questions most frequently asked by regulators during implementation workshops for WHO guideline document.

WHO has asked for stakeholders to submit written comments on the draft Q&A document to the Department of Essential Medicines and Health Products. Any comments on the new Q&A should be received by WHO by 20 September 2018.

The draft, and comments on it, will be discussed at WHO’s Expert Committee on Biological Standardization, which will be held in Geneva, Switzerland on 29 October to 2 November 2018. After the Committee has had the opportunity to review the comments and discuss any alterations to the document, the outcome of its deliberations will be published in the WHO Technical Report Series.

In May 2017, WHO also announced that it would be launching its pilot project for prequalifying biosimilars in October 2017. The move was intended to make ‘some of the most expensive treatments for cancer more widely available in low- and middle-income countries’ [1]. The pilot prequalification project covering rituximab and trastuzimab was finally launched in July 2018.

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1.  GaBI Online - Generics and Biosimilars Initiative. WHO launches consultation on prequalification of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 14]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-consultation-on-prequalification-of-biosimilars

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Source: WHO

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