title: The use of pharmacometrics to optimize biosimilar development.
abstract: Pharmacometric approaches can assist in biosimilar development by leveraging quantitative knowledge of the originator product characteristics such as dose-exposure and exposure-response information to support a targeted approach to clinical studies. The degree to which these approaches can be applied relies on the level of information known about the originator and information that supports application of the originator model to the biosimilar. A model-based approach testing the hypothesis that the biosimilar PK and/or PK/PD profile is similar to the originator in the target patient population is aligned with the central comparability exercise required for the biosimilar approval. This Commentary details the key opportunities in study design and study analysis where pharmacometrics approaches can aid biosimilar development.
authors.affiliation: Pharmacokinetics & Drug Metabolism, Amgen Inc., Seattle, Washington, 98119.
authors.forename: Mike
authors.initials: M
authors.lastname: Dodds
authors.forename: Vincent
authors.initials: V
authors.lastname: Chow
authors.forename: Richard
authors.initials: R
authors.lastname: Markus
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Pérez-Ruixo
authors.forename: Danny
authors.initials: D
authors.lastname: Shen
authors.forename: Megan
authors.initials: M
authors.lastname: Gibbs
mesh_terms: D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000493:pharmacokinetics* / Q000494:pharmacology*; D002986:Clinical Trials as Topic / Q000379:methods; D003198:Computer Simulation; D017277:Drug Approval / Q000379:methods*; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D008954:Models, Biological; D013810:Therapeutic Equivalency
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: bioequivalence; clinical paharmacokinetics; pharmacodynamics; pharmacokinetics/pharmacodynamics; population pharmacokinetics; trial simulation