Affiliations 

  • 1 Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria. Electronic address: martin.schiestl@sandoz.com
  • 2 Shanghai CP-Guojian Pharmaceutical Co., Ltd, China
  • 3 National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Jalan University, Malaysia
  • 4 Centre of Molecular Immunology, Cuba
  • 5 Hospira, Australia
  • 6 National Institute for Food and Drug Control (NIFDC), China
  • 7 Korea Food and Drug Administration, Republic of Korea
  • 8 Pfizer Inc., USA
  • 9 Health Products Regulation Group (HPRG), Singapore
  • 10 World Health Organization, Switzerland
Biologicals, 2014 Mar;42(2):128-32.
PMID: 24373974 DOI: 10.1016/j.biologicals.2013.11.009

Abstract

A determination of biosimilarity is based on a thorough characterization and comparison of the quality profiles of a similar biotherapeutic product and its reference biotherapeutic product. Although the general principles on the role of the quality assessment in a biosimilar evaluation are widely understood and agreed, detailed discussions have not been published yet. We try to bridge this gap by presenting a case study exercise based on fictional but realistic data to highlight key principles of an evaluation to determine the degree of similarity at the quality level. The case study comprises three examples for biosimilar monoclonal antibody candidates. The first describes a highly similar quality profile whereas the second and third show greater differences to the reference biotherapeutic product. The aim is to discuss whether the presented examples can be qualified as similar and which additional studies may be helpful in enabling a final assessment. The case study exercise was performed at the WHO implementation workshop for the WHO guidelines on quality assessment of similar biotherapeutic products held in Xiamen, China, in May 2012. The goal was to illustrate the interpretation of the comparative results at the quality level, the role of the quality assessment in the entire biosimilarity exercise and its influence on the clinical evaluation. This paper reflects the outcome of the exercise and discussion from Xiamen.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.