WHO Posts Q&A to Clarify Guidelines on Biosimilars

The World Health Organization (WHO) invited comments on a draft question-and-answer document that aims to clarify its 2009 guidelines on the evaluation of biosimilars.

The Q&A deals with basic questions such as the meaning of the term similar biotherapeutic products (SBPs) as well as more complex issues, such as how to handle differences in immunogenicity and the duration of clinical studies.

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