Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars)

Robin Thorpe; Meenu Wadhwa

doi:10.1016/j.biologicals.2011.06.005

Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars)

Biologicals. 2011 Sep;39(5):262-5. doi: 10.1016/j.biologicals.2011.06.005. Epub 2011 Aug 30.

Authors

Robin Thorpe¹, Meenu Wadhwa

Affiliation

¹ Biotherapeutics Group, National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Herts, UK. Robin.Thorpe@nibsc.hpa.org.uk

PMID: 21880508
DOI: 10.1016/j.biologicals.2011.06.005

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.

Publication types

Review

MeSH terms

Drug Industry / legislation & jurisprudence
Drug Industry / standards*
Legislation, Drug*
Pharmaceutical Preparations / standards*
Reference Standards
World Health Organization*

Substances

Pharmaceutical Preparations