Intended use of Reference Products & WHO International Standards/Reference Reagents in the development of Similar Biological Products (Biosimilars)

Reference Products and WHO International Standards/Reference Reagents have roles to play in the development and characterization of similar biological products (SBPs). However, these roles are distinct and non-interchangeable. The uses of these materials and their limitations are considered in this paper. (C) World Health Organization 2011. All rights reserved. The World Health Organization has granted the Publisher permission for the reproduction of this article.