Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs), Annex 2, TRS No 1004

Overview

Monoclonal antibodies (mAbs) are a major class of recombinant deoxyribonucleic acid (rDNA) technology-derived biotherapeutic products that have achieved outstanding success in treating many life-threatening and chronic diseases. Some of these targeted therapy products are ranked in the top-10 lists of annual global pharmaceutical revenue sources. As patents and data-protection measures on mAb products have expired, or are nearing expiry, considerable attention has turned towards producing similar biotherapeutic products (SBPs, also termed “biosimilars”) based upon the approved mAb innovator products, with a view to making more affordable products that could improve global access to these so‑called blockbusters.

The WHO Guidelines on evaluation of similar biotherapeutic products (SBPs) were adopted by the WHO Expert Committee on Biological Standardization in 2009. This document set out the scientific principles, including the stepwise approach, which should be applied for the demonstration of similarity between an SBP and the reference biotherapeutic product (RBP). The intention of this class-specific document is to set out the specific considerations involved in the evaluation of mAbs developed as SBPs. These WHO Guidelines cover rDNA-derived biosimilar mAbs used in the treatment of human diseases. The principles discussed in this document also apply to mAb-derived proteins – for example, mAb fragments and Fc fusion proteins.

Full version of the WHO Technical Report Series N° 1004