International – 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…