title: Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars).
abstract: 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.
authors: Biotherapeutics Group, National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Herts, UK. Robin.Thorpe@nibsc.hpa.org.uk
authors: Robin
authors: R
authors: Thorpe
authors: Meenu
authors: M
authors: Wadhwa
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000592:standards*; D012015:Reference Standards; D014944:World Health Organization
chemical_list: D004364:Pharmaceutical Preparations