WHO Opens Consultation on New Biosimilar Q&A
As part of plans to clarify earlier biosimilar guidance, the World Health Organization (WHO) has drafted a new document outlining answers to questions regulators posed over the past eight years.The more than 30 pages of questions and answers – most of which fall into the quality and clinical evaluation sections – range from the most basic, “What is a similar biotherapeutic product (SBP)?” to more complex questions, like: “Would it be beneficial to review/discuss post-marketing commitments from each NRA [national regulatory authority] after extrapolation of indications?”
“The intention is to update the Q&As regularly to reflect new developments and issues that arise, but not to address issues of interchangeability, switching, substitution, naming or shortages which are out of the scope of the original guidelines,” WHO said.
The Q&A is divided into six sections:
- Concept for licensing similar biotherapeutic products;
- Reference biotherapeutic products;
- Quality;
- Nonclinical evaluation;
- Clinical evaluation;
- Pharmacovigilance.
Background
The creation of the Q&A follows the 2009 “Guidelines on evaluation of similar biotherapeutic products (SBPs)” and in 2016 another guideline on monoclonal antibody biosimilars.
In May 2017, WHO held a consultation on improving access to and use of similar biotherapeutic products. From the outcome of this consultation, WHO noted that developing a Q&A document is “more appropriate than revising previous guidance for further clarifying and complementing some areas and points written in the guidelines.”
WHO Questions and Answers: Similar Biotherapeutic Products