At the 17th Biosimilar Medicines Conference in The Netherlands, the World Health Organization (WHO) outlined a new Q&A document to assist with the regulatory evaluation of biosimilar products.
WHO’s official guidelines on the evaluation of biosimilars (referred to as similar biotherapeutic products or SBPs) were adopted by the Expert Committee on Biological Standardization (ECBS) in 2009 [1].
In 2014 however, the 67th World Health Assembly adopted a resolution on improving access to biological drugs and ensuring their safety, quality and efficacy. This included a request to update the 2009 guidelines, taking into account ‘technological advances for the characterization of biological drugs’ and ‘national regulatory needs’.
WHO subsequently held a series of meetings, leading to the conclusion that there was no need to revise the guidelines themselves, but there was a need for additional guidance on the evaluation of SBPs.
WHO’s Regulation of Medicines and other Health Technologies (RHT) Department detailed this additional guidance at the Biosimilar Medicines Conference on 29 March 2019.
This Q&A document complements the existing guidelines and deals with a number of issues regarding licensing SBPs, reference biological products, quality, non-clinical and clinical evaluation and pharmacovigilance. It was composed based on questions frequently asked by regulators during implementation workshops on the 2009 WHO Guidelines.
The Q&A was first drafted in 2018, with comments returned by 20 September 2018 [2]. The final version incorporating those comments addresses the following major questions (among others):
• What is a similar biotherapeutic product (SBP)?
• How are SBPs evaluated for licensing?
• Which products can be approved as SBPs?
• What is a reference biotherapeutic product (RBP)?
• When is it acceptable to use an RBP sourced from another country?
• Should the expression system used in producing an SBP be the same as that used to produce the RBP?
• How many batches should be analyzed in comparability studies?
• What factors should be considered in planning and conducting non-clinical studies for an SBP?
• Which factors should be considered in terms of the immunogenicity of an SBP?
• Are SBPs as safe as originator products?
• Can the SBP marketing authorization holder seek approval for a new indication, dosage form or route of administration different from the RBP?
The Q&A has been adopted by the ECBS and aims to clarify the guiding principles included in the guidelines on SBPs (including monoclonal antibodies). Combined, these documents represent the latest guidance on evaluation of biosimilars from WHO.
The Organization is providing technical support on the evaluation of biosimilars through workshops with the support of the relevant national regulatory agency (NRA), as well as case studies on study design and quality and immunogenicity assessment.
The document is available in full here. WHO states that the document is for guidance only and should be read ‘conjunction with relevant WHO guidelines’.
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References
1. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 977, 2009 [homepage on the Internet. [cited 2019 Apr 19]. Available from: https://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1
2. GaBI Online - Generics and Biosimilars Initiative. WHO asks for comments on new biosimilar Q&A [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from: www:gabionline.net/Guidelines/WHO-asks-for-comments-on-new-biosimilar-Q-A
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