title: Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.
abstract: For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared to the reference product. Therefore, pharmacokinetic (PK) and immunogenicity (antidrug antibody, ADA) assays that allow for the demonstration of biosimilarity are critical. Under the auspices of the American Association of Pharmaceutical Scientists (AAPS) Ligand-Binding Assay Bioanalytical Focus Group (LBABFG), a Biosimilars Action Program Committee (APC) was formed in 2011. The goals of this Biosimilars APC were to provide a forum for in-depth discussions on issues surrounding the development and validation of PK and immunogenicity assays in support of biosimilar drug development and to make recommendations thereof. The Biosimilars APC's recommendations for the development and validation of ligand-binding assays (LBAs) to support the PK assessments for biosimilar drug development are presented here. Analytical recommendations for the development and validation of LBAs to support immunogenicity assessments will be the subject of a separate white paper.
authors.affiliation: Janssen Research and Development, LLC, 1400 McKean Road,, PO Box 1776, Spring House, Pennsylvania, 19477, USA, jmarini@its.jnj.com.
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Marini
authors.forename: Michael
authors.initials: M
authors.lastname: Anderson
authors.forename: Xiao-Yan
authors.initials: XY
authors.lastname: Cai
authors.forename: John
authors.initials: J
authors.lastname: Chappell
authors.forename: Todd
authors.initials: T
authors.lastname: Coffey
authors.forename: Dominique
authors.initials: D
authors.lastname: Gouty
authors.forename: Aparna
authors.initials: A
authors.lastname: Kasinath
authors.forename: Vera
authors.initials: V
authors.lastname: Koppenburg
authors.forename: Philip
authors.initials: P
authors.lastname: Oldfield
authors.forename: Shannon
authors.initials: S
authors.lastname: Rebarchak
authors.forename: Ronald R
authors.initials: RR
authors.lastname: Bowsher
mesh_terms: D001681:Biological Assay / Q000379:methods* / Q000592:standards; D059451:Biosimilar Pharmaceuticals / Q000493:pharmacokinetics*; D002138:Calibration; D055808:Drug Discovery; D008024:Ligands; D017410:Practice Guidelines as Topic; D011869:Radioligand Assay / Q000379:methods* / Q000592:standards; D012015:Reference Standards; D054928:Validation Studies as Topic
chemical_list: D059451:Biosimilar Pharmaceuticals; D008024:Ligands