Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, TRS No 977

Overview

Biotherapeutic products (biotherapeutics) have a successful record in treating many life-threatening and chronic diseases. However, their cost has often been  high, thereby limiting their accessibility to patients, particularly in developing countries. Recently, the expiry of patents and/or data protection for the first  major group of originator’s biotherapeutics has ushered in an era of products that are designed to be “similar” to a licensed originator product. These products  rely for their licensing partly on prior information regarding safety and efficacy obtained with the originator products. The clinical experience and established  safety profile of the originator products should contribute to the development of similar biotherapeutic products (SBPs). A variety of terms, such as “biosimilar  products”, “follow-on protein products” and “subsequent-entry biologics” have been coined to describe these products.

This document is intended to provide guidance for the development and evaluation of such biotherapeutics; it should be viewed as a “living” document that will be developed further in line with advances in scientific knowledge and experience. 

Full version of the WHO Technical Report Series N° 977