WHO Questions and Answers: Similar Biotherapeutic Products

Overview

The WHO Guidelines on evaluation of similar biotherapeutic products (SBPs) were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2009, and have raised awareness of the complex scientific issues related to the licensing of SBPs. However, in some countries and for a variety of reasons, biotherapeutic products have been licensed as generics or as small molecule drugs using data which do not now meet current WHO regulatory expectations. Very little is known about the safety and efficacy of these individual products. Consequently, these products need to be reassessed by national regulatory authorities (NRAs), as described in the WHO guidance document on Regulatory assessment of approved rDNA-derived biotherapeutics.