title: The role of the quality assessment in the determination of overall biosimilarity: a simulated case study exercise.
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.
authors.affiliation: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria. Electronic address: martin.schiestl@sandoz.com.
authors.forename: Martin
authors.initials: M
authors.lastname: Schiestl
authors.affiliation: Shanghai CP-Guojian Pharmaceutical Co., Ltd, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Jalan University, Malaysia.
authors.forename: Arpah
authors.initials: A
authors.lastname: Abas
authors.affiliation: Centre of Molecular Immunology, Cuba.
authors.forename: Antonio
authors.initials: A
authors.lastname: Vallin
authors.affiliation: Hospira, Australia.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Millband
authors.affiliation: National Institute for Food and Drug Control (NIFDC), China.
authors.forename: Kai
authors.initials: K
authors.lastname: Gao
authors.affiliation: Korea Food and Drug Administration, Republic of Korea.
authors.forename: Jeewon
authors.initials: J
authors.lastname: Joung
authors.affiliation: Pfizer Inc., USA.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Pluschkell
authors.affiliation: Health Products Regulation Group (HPRG), Singapore.
authors.forename: Thomas
authors.initials: T
authors.lastname: Go
authors.affiliation: World Health Organization, Switzerland.
authors.forename: Hye-Na
authors.initials: HN
authors.lastname: Kang
mesh_terms: D001688:Biological Products / Q000592:standards*; D011786:Quality Control
chemical_list: D001688:Biological Products
keywords: Biosimilar; Quality assessment; Similar biotherapeutic products; WHO; Xiamen case study